Instrumentais para Prótese Total de Joelho Unity
Nome do produto
Instrumentais para Prótese Total de Joelho Unity
Número de registro
80346180007
Nome técnico
Classe de risco
I
Processo
25351012533202037
Fabricante
País de fabricação
REINO UNIDO
Apresentações / Modelos(325)
A123.054.00-IM DRILL (AO)
A123.065.00-TIBIAL STEM DRILL (AO)
A123.066.00-FEMORAL PEG DRILL (AO)
A123.083.50-PATELLA PEG DRILL (AO)
A123.342.30-FEMORAL PS BOX REAMER (AO)
A123.350.00-PIN DRIVER (AO)
CG000033-Tibial Resection Top Tray
CG000034Femoral Resection Bottom Tray
CG000037-Femoral CR Trials Top Tray Sizes 3 to 8
CG000038-Tibial Insert Trials Bottom Tray Sizes 3 to 8
CG000039-Macro Size 9 Top Tray
CG000040Patella Resection Bottom Tray
CG000041-Femoral PS Trials Top Tray Sizes 3 to 8
CG000042-Optional Instruments Bottom Tray
CG000094-STEM IMPACTION CAP Ø10.0
CG000095-STEM IMPACTION CAP Ø14.0
CG000145-IMPLANT STEM ASSEMBLY PLATE
CG000147-TRIAL TIBIAL STEM EXTENSION Ø10 L30
CG000148-TRIAL TIBIAL STEM EXTENSION Ø10 L60
CG000149-TRIAL TIBIAL STEM EXTENSION Ø10 L100
CG000154-TRIAL TIBIAL STEM EXTENSION Ø14 L30
CG000155-TRIAL TIBIAL STEM EXTENSION Ø14 L60
CG000156-TRIAL TIBIAL STEM EXTENSION Ø14 L100
CG000159-TRIAL FEMORAL STEM EXTENSION Ø10 L30
CG000160-TRIAL FEMORAL STEM EXTENSION Ø10 L60
CG000161-TRIAL FEMORAL STEM EXTENSION Ø10 L100
CG000163-TRIAL FEMORAL STEM EXTENSION Ø14 L30
CG000164-TRIAL FEMORAL STEM EXTENSION Ø14 L60
CG000165-TRIAL FEMORAL STEM EXTENSION Ø14 L100
CG000166-TORQUE HANDLE 2Nm
CG000167-HEX ATTACHMENT 2.5mm
CG000168-Ø10.0 DRILL (ZIMMER DRIVE)
CG000169-Ø14.0 DRILL (ZIMMER DRIVE)
CG000171-Ø10.0 DRILL (AO DRIVE)
CG000172-Ø14.0 DRILL (AO DRIVE)
CG000173-Ø10.0 DRILL (HUDSON DRIVE)
CG000174-Ø14.0 DRILL (HUDSON DRIVE)
CG000187-PS BOX SAW RESECTION GUIDE SIZE 3 TO 7
CG000188-PS BOX SAW RESECTION GUIDE SIZE 8 & 9
CG000189-General Instrument Top Tray
CG000190-General Instrument Bottom Tray
CG000196-DRILL GUIDE Ø9
CG000197-DRILL GUIDE Ø10
CG000198-DRILL GUIDE Ø13
CG000199-DRILL GUIDE Ø14
CG000200-FEMORAL DRILL GUIDE BODY
CG000204-Ø9.0 DRILL (ZIMMER DRIVE)
CG000205-Ø13.0 DRILL (ZIMMER DRIVE)
CG000206-Ø9.0 DRILL (HUDSON DRIVE)
CG000207-Ø13.0 DRILL (HUDSON DRIVE)
CG000208-Ø9.0 DRILL (AO DRIVE)
CG000209-Ø13.0 DRILL (AO DRIVE)
CG000211-FEMORAL DRILL GUIDE BUSHING
CG000212-DPI STEM EXTENSION PREPARATION (UPPER TRAY)
CG000214-DPI AUGMENT PREPARATION (LOWER TRAY)
H123.054.00-IM DRILL (HUDSON)
H123.065.00-TIBIAL STEM DRILL (HUDSON)
H123.066.00-FEMORAL PEG DRILL (HUDSON)
H123.083.50-PATELLA PEG DRILL (HUDSON)
H123.342.30-FEMORAL PS BOX REAMER (HUDSON)
H123.350.00-PIN DRIVER (HUDSON)
T123.997.00-FEMORAL PREPARATION – TOP LAYER
T123.997.01-FEMORAL PREPARATION – BOTTOM LAYER
T123.997.02-TIBIAL PREPARATION – TOP LAYER
T123.997.03-TIBIAL PREPARATION – BOTTOM LAYER
T123.997.04-GENERAL INSTRUMENTS – TOP LAYER
T123.997.05-GENERAL INSTRUMENTS – BOTTOM LAYER
T123.997.06-TRIAL SIZES 4 TO 7 – TOP LAYER
T123.997.07-TRIAL SIZES 4 TO 7 – BOTTOM LAYER
T123.997.08-TRIAL SIZES 3 AND 8 ONLY – TOP LAYER
T123.997.09-PATELLA PREPARATION – BOTTOM LAYER
T123.997.10-TIBIAL INSERTS 18mm TO 20mm – TOP LAYER
T123.997.11-MACRO SIZE 9 INSTRUMENTS – BOTTOM LAYER
T123.999-UNITY KNEE BOX ASSEMBLY
123.003.05- FEMORAL SIZER ML WIDTH CHECKER SIZES 3 TO 7
123.003.08- FEMORAL SIZER ML WIDTH CHECKER SIZES 8 & 9
123.007.00- DISTAL FEMORAL CUTTING BLOCK
123.008.50- EM TIBIAL ANKLE CLAMP
123.008.60- EM TIBIAL AP/ML ANKLE GUIDE
123.042.20- CHAIN DRILL GUIDE
123.043.00- PS BOX CUTTING GUIDE SIZES 8 & 9
123.043.40- PS BOX CHISEL SIZES 8 & 9
123.044.00- ALIGNMENT GUIDE
123.045.01- FEMALE ALIGNMENT ROD
123.045.02- MALE ALIGNMENT ROD
123.052.00- MODULAR HANDLE
123.053.00- IM ROD
123.054.00- IM DRILL (ZIMMER)
123.059.00- 4:1 CUT BLOCK DRILL (ZIMMER)
123.061.10- TIBIAL KEEL PUNCH SIZES 1 TO 3
123.061.20- TIBIAL KEEL PUNCH SIZES 4 TO 6
123.061.30- TIBIAL KEEL PUNCH SIZES 7 TO 9
123.063.00- KEEL PUNCH QUICK RELEASE CONNECTOR
123.065.00- TIBIAL STEM DRILL (ZIMMER)
123.066.00- FEMORAL PEG DRILL (ZIMMER)
123.071.00- PATELLA RESECTION CLAMP
123.072.00- TIBIA BASEPLATE IMPACTOR
123.074.00- ANGEL WING
123.075.01- DOME PATELLA TRIAL 3 PEG SIZE 1
123.075.02- DOME PATELLA TRIAL 3 PEG SIZE 2
123.075.03- DOME PATELLA TRIAL 3 PEG SIZE 3
123.075.04- DOME PATELLA TRIAL 3 PEG SIZE 4
123.075.05- DOME PATELLA TRIAL 3 PEG SIZE 5
123.075.11- OFFSET DOME PATELLA TRIAL 3 PEG SIZE 1
123.075.12- OFFSET DOME PATELLA TRIAL 3 PEG SIZE 2
123.075.13- OFFSET DOME PATELLA TRIAL 3 PEG SIZE 3
123.075.14- OFFSET DOME PATELLA TRIAL 3 PEG SIZE 4
123.076.00- PATELLA CALIPER
123.077.00- TIBIA INSERT IMPACTOR
123.079.00- SLAP HAMMER
123.081.00- EQUIBALANCE LIGAMENT BALANCER
123.082.00- GAP CHECKER
123.083.00- PATELLA COMPRESSION CLAMP
123.083.30- PATELLA COMPRESSION ATTACHMENT
123.083.41- PATELLA DRILL GUIDE DOME SIZE 1
123.083.42- PATELLA DRILL GUIDE DOME SIZE 2
123.083.43- PATELLA DRILL GUIDE DOME SIZE 3
123.083.44- PATELLA DRILL GUIDE DOME SIZE 4
123.083.45- PATELLA DRILL GUIDE DOME SIZE 5
123.083.50- PATELLA PEG DRILL (ZIMMER)
123.083.61- PATELLA DRILL GUIDE OFFSET DOME SIZE 1
123.083.62- PATELLA DRILL GUIDE OFFSET DOME SIZE 2
123.083.63- PATELLA DRILL GUIDE OFFSET DOME SIZE 3
123.083.64- PATELLA DRILL GUIDE OFFSET DOME SIZE 4
123.085.00- PIN PULLER
123.087.00- T-HANDLE
123.088.00- BONE FILE
123.090.01- SPACER SHIM 1mm
123.090.02- SPACER SHIM 2mm
123.091.00- FEMORAL FINAL IMPACTOR
123.113.00- TRIAL EXTRACTOR
123.114.00- FEMORAL INTRODUCER / EXTRACTOR
123.116.00- EQUIBALANCE LIGAMENT TENSIONER
123.116.23- TENSIONER PADDLE EXTENSION
123.116.24- TENSIONER PADDLE FLEXION
123.301.00- FEMORAL SIZER
123.302.00- FEMORAL SIZER STYLUS
123.305.01- TIBIAL CUTTING BLOCK LEFT
123.305.02- TIBIAL CUTTING BLOCK RIGHT
123.306.00- DISTAL IM FEMORAL ALIGNMENT JIG
123.308.00- EM TOWER WITH MACRO ADJUSTMENT
123.308.28- EM TIBIAL JIG MICRO ADJUSTMENT ASSEMBLY
123.309.00- EM TIBIAL SPIKE
123.310.00- TIBIAL STYLUS
123.325.00- 4:1 CUTTING BLOCK SIZE 3
123.326.00- 4:1 CUTTING BLOCK SIZE 4
123.327.00- 4:1 CUTTING BLOCK SIZE 5
123.328.00- 4:1 CUTTING BLOCK SIZE 6
123.329.00- 4:1 CUTTING BLOCK SIZE 7
123.330.00- 4:1 CUTTING BLOCK SIZE 8
123.331.00- 4:1 CUTTING BLOCK SIZE 9
123.342.00- PS BOX CUTTING GUIDE SIZES 3 TO 7
123.342.02- MONOBLOCK BOX CUTTING GUIDE SIZES 3 TO 7
123.342.03- MONOBLOCK BOX CUTTING GUIDE SIZES 8 & 9
123.342.30- FEMORAL PS BOX REAMER (ZIMMER)
123.342.40- PS BOX CHISEL SIZES 3 TO 7
123.346.00- DRIVEN COLLARLESS PINS LONG
123.347.00- DRIVEN COLLARED PINS LONG
123.347.02- DRIVEN COLLARED PINS SHORT
123.350.00- PIN DRIVER (ZIMMER)
123.355.03- TIBIAL TEMPLATE TRIAL SIZE 3
123.355.04- TIBIAL TEMPLATE TRIAL SIZE 4
123.355.05- TIBIAL TEMPLATE TRIAL SIZE 5
123.355.06- TIBIAL TEMPLATE TRIAL SIZE 6
123.355.07- TIBIAL TEMPLATE TRIAL SIZE 7
123.355.08- TIBIAL TEMPLATE TRIAL SIZE 8
123.355.09- TIBIAL TEMPLATE TRIAL SIZE 9
123.357.00- KEEL PUNCH GUIDE
123.364.00- TIBIAL TEMPLATE HANDLE
123.367.03- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 3
123.367.04- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 4
123.367.05- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 5
123.367.06- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 6
123.367.07- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 7
123.367.08- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 8
123.367.09- PS MONOBLOCK FEMORAL TRIAL LEFT SIZE 9
123.367.13- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 3
123.367.14- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 4
123.367.15- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 5
123.367.16- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 6
123.367.17- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 7
123.367.18- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 8
123.367.19- PS MONOBLOCK FEMORAL TRIAL RIGHT SIZE 9
123.368.03- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 3
123.368.04- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 4
123.368.05- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 5
123.368.06- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 6
123.368.07- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 7
123.368.08- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 8
123.368.09- CR MONOBLOCK FEMORAL TRIAL LEFT SIZE 9
123.368.13- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 3
123.368.14- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 4
123.368.15- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 5
123.368.16- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 6
123.368.17- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 7
123.368.18- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 8
123.368.19- CR MONOBLOCK FEMORAL TRIAL RIGHT SIZE 9
123.369.13- CR TIBIAL INSERT TRIAL SIZE 3 -9mm
123.369.14- CR TIBIAL INSERT TRIAL SIZE 4 - 9mm
123.369.15- CR TIBIAL INSERT TRIAL SIZE 5 - 9mm
123.369.16- CR TIBIAL INSERT TRIAL SIZE 6 - 9mm
123.369.17- CR TIBIAL INSERT TRIAL SIZE 7 -9mm
123.369.18- CR TIBIAL INSERT TRIAL SIZE 8 -9mm
123.369.19- CR TIBIAL INSERT TRIAL SIZE 9 -9mm
123.369.23- CR TIBIAL INSERT TRIAL SIZE 3 - 10mm
123.369.24- CR TIBIAL INSERT TRIAL SIZE 4 -10mm
123.369.25- CR TIBIAL INSERT TRIAL SIZE 5 -10mm
123.369.26- CR TIBIAL INSERT TRIAL SIZE 6 -10mm
123.369.27- CR TIBIAL INSERT TRIAL SIZE 7 -10mm
123.369.28- CR TIBIAL INSERT TRIAL SIZE 8 -10mm
123.369.29- CR TIBIAL INSERT TRIAL SIZE 9 -10mm
123.369.33- CR TIBIAL INSERT TRIAL SIZE 3 - 11mm
123.369.34- CR TIBIAL INSERT TRIAL SIZE 4 -11mm
123.369.35- CR TIBIAL INSERT TRIAL SIZE 5 - 11mm
123.369.36- CR TIBIAL INSERT TRIAL SIZE 6 -11mm
123.369.37- CR TIBIAL INSERT TRIAL SIZE 7 - 11mm
123.369.38- CR TIBIAL INSERT TRIAL SIZE 8 -11mm
123.369.39- CR TIBIAL INSERT TRIAL SIZE 9 -11mm
123.369.43- CR TIBIAL INSERT TRIAL SIZE 3 -12mm
123.369.44- CR TIBIAL INSERT TRIAL SIZE 4 -12mm
123.369.45- CR TIBIAL INSERT TRIAL SIZE 5 -12mm
123.369.46- CR TIBIAL INSERT TRIAL SIZE 6 -12mm
123.369.47- CR TIBIAL INSERT TRIAL SIZE 7 -12mm
123.369.48- CR TIBIAL INSERT TRIAL SIZE 8 -12mm
123.369.49- CR TIBIAL INSERT TRIAL SIZE 9 -12mm
123.369.53- CR TIBIAL INSERT TRIAL SIZE 3 -14mm
123.369.54- CR TIBIAL INSERT TRIAL SIZE 4 -14mm
123.369.55- CR TIBIAL INSERT TRIAL SIZE 5 -14mm
123.369.56- CR TIBIAL INSERT TRIAL SIZE 6 -14mm
123.369.57- CR TIBIAL INSERT TRIAL SIZE 7 - 14mm
123.369.58- CR TIBIAL INSERT TRIAL SIZE 8 - 14mm
123.369.59- CR TIBIAL INSERT TRIAL SIZE 9 -14mm
123.369.63- CR TIBIAL INSERT TRIAL SIZE 3 - 16mm
123.369.64- CR TIBIAL INSERT TRIAL SIZE 4 - 16mm
123.369.65- CR TIBIAL INSERT TRIAL SIZE 5 -16mm
123.369.66- CR TIBIAL INSERT TRIAL SIZE 6 -16mm
123.369.67- CR TIBIAL INSERT TRIAL SIZE 7 -16mm
123.369.68- CR TIBIAL INSERT TRIAL SIZE 8 - 16mm
123.369.69- CR TIBIAL INSERT TRIAL SIZE 9 -16mm
123.369.73- CR TIBIAL INSERT TRIAL SIZE 3 -18mm
123.369.74- CR TIBIAL INSERT TRIAL SIZE 4 -18mm
123.369.75- CR TIBIAL INSERT TRIAL SIZE 5 -18mm
123.369.76- CR TIBIAL INSERT TRIAL SIZE 6 - 18mm
123.369.77- CR TIBIAL INSERT TRIAL SIZE 7 -18mm
123.369.78- CR TIBIAL INSERT TRIAL SIZE 8 -18mm
123.369.79- CR TIBIAL INSERT TRIAL SIZE 9 - 18mm
123.369.83- CR TIBIAL INSERT TRIAL SIZE 3 -20mm
123.369.84- CR TIBIAL INSERT TRIAL SIZE 4 -20mm
123.369.85- CR TIBIAL INSERT TRIAL SIZE 5 -20mm
123.369.86- CR TIBIAL INSERT TRIAL SIZE 6 -20mm
123.369.87- CR TIBIAL INSERT TRIAL SIZE 7 -20mm
123.369.88- CR TIBIAL INSERT TRIAL SIZE 8 -20mm
123.369.89- CR TIBIAL INSERT TRIAL SIZE 9 -20mm
123.370.20- MODULAR PS POST SIZES 3 TO 9
123.370.90- PS POST EXTRACTION TOOL
123.371.00- FEMORAL TRIAL EXTRACTION TOOL
123.467.03- PS ATTACHMENT LEFT SIZE 3
123.467.04- PS ATTACHMENT LEFT SIZE 4
123.467.05- PS ATTACHMENT LEFT SIZE 5
123.467.06- PS ATTACHMENT LEFT SIZE 6
123.467.07- PS ATTACHMENT LEFT SIZE 7
123.467.08- PS ATTACHMENT LEFT SIZE 8
123.467.09- PS ATTACHMENT LEFT SIZE 9
123.467.13- PS ATTACHMENT RIGHT SIZE 3
123.467.14- PS ATTACHMENT RIGHT SIZE 4
123.467.15- PS ATTACHMENT RIGHT SIZE 5
123.467.16- PS ATTACHMENT RIGHT SIZE 6
123.467.17- PS ATTACHMENT RIGHT SIZE 7
123.467.18- PS ATTACHMENT RIGHT SIZE 8
123.467.19- PS ATTACHMENT RIGHT SIZE 9
123.468.03- CR ATTACHMENT LEFT SIZE 3
123.468.04- CR ATTACHMENT LEFT SIZE 4
123.468.05- CR ATTACHMENT LEFT SIZE 5
123.468.06- CR ATTACHMENT LEFT SIZE 6
123.468.07- CR ATTACHMENT LEFT SIZE 7
123.468.08- CR ATTACHMENT LEFT SIZE 8
123.468.09- CR ATTACHMENT LEFT SIZE 9
123.468.13- CR ATTACHMENT RIGHT SIZE 3
123.468.14- CR ATTACHMENT RIGHT SIZE 4
123.468.15- CR ATTACHMENT RIGHT SIZE 5
123.468.16- CR ATTACHMENT RIGHT SIZE 6
123.468.17- CR ATTACHMENT RIGHT SIZE 7
123.468.18- CR ATTACHMENT RIGHT SIZE 8
123.468.19- CR ATTACHMENT RIGHT SIZE 9
123.473.03- FEMORAL TRIAL LEFT SIZE 3
123.473.04- FEMORAL TRIAL LEFT SIZE 4
123.473.05- FEMORAL TRIAL LEFT SIZE 5
123.473.06- FEMORAL TRIAL LEFT SIZE 6
123.473.07- FEMORAL TRIAL LEFT SIZE 7
123.473.08- FEMORAL TRIAL LEFT SIZE 8
123.473.09- FEMORAL TRIAL LEFT SIZE 9
123.473.13- FEMORAL TRIAL RIGHT SIZE 3
123.473.14- FEMORAL TRIAL RIGHT SIZE 4
123.473.15- FEMORAL TRIAL RIGHT SIZE 5
123.473.16- FEMORAL TRIAL RIGHT SIZE 6
123.473.17- FEMORAL TRIAL RIGHT SIZE 7
123.473.18- FEMORAL TRIAL RIGHT SIZE 8
123.473.19- FEMORAL TRIAL RIGHT SIZE 9
123.483.00- GAP CHECKER MAIN BODY
123.483.23- GAP CHECKER SHIM 9mm THICK
123.483.24- GAP CHECKER SHIM 10mm THICK
123.483.25- GAP CHECKER SHIM 11mm THICK
123.483.26- GAP CHECKER SHIM 12mm THICK
123.483.27- GAP CHECKER SHIM 14mm THICK
123.483.28- GAP CHECKER SHIM 16mm THICK
123.483.29- GAP CHECKER SHIM 18mm THICK
123.483.30- GAP CHECKER SHIM 20mm THICK
123.525.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 3
123.526.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 4
123.527.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 5
123.528.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 6
123.529.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 7
123.530.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 8
123.531.00- ACCELERATE 4:1 CUTTING BLOCK SIZE 9
123.904.00- CONTAINER LID – UNITY KNEE GENERIC
1230010- DPI PLATFORM BOX LID
1230096- FEMORAL STEM REAMER
255.990- PIN BOX
279.018- HEX SCREWDRIVER 3.5 A/F
291.617- PIN IMPACTOR
399.014.001- INSTRUMENT OUTER BOX – FULL HEIGHT
496.027- SINGLE HEIGHT AEXCULAP BOX WITH LID
496.028- FULL HEIGHT AESCULAP BOX WITH LID
A123.059.00-4:1 CUT BLOCK DRILL (AO)
H123.059.00-4:1 CUTTING BLOCK DRILL (HUDSON)
Instruções de Uso e Arquivos(1)
| Código | Tipo | Arquivo | Expedição | Expediente |
|---|---|---|---|---|
| T15202753 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | Instrução de Uso_Instrumentais para Prótese Total de Joelho Unity_.pdf | 06/10/2021, 11:48 | 3939684210 |
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
A atualização destes documentos é executada pela empresa responsável pela regularização do produto.
Documentos Técnicos(2)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 0355333207 | 23/04/2021 | MATERIAL - Retificação – Correção pela ANVISA | Publicado deferimento |
| 0069947201Primária | 16/01/2020 | MATERIAL – Notificação de Dispositivo Médico Classe I | Publicado deferimento |
MATERIAL - Retificação – Correção pela ANVISA
Publicado deferimento
MATERIAL – Notificação de Dispositivo Médico Classe I
Publicado deferimento
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