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Depuy Orthopaedic Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6020-22-000Model TISSUE SPARING SOLUTIONS Orthopaedic Chisel/Osteotome
Identity
- Trade Name
- DEPUY ORTHOPAEDIC INSTRUMENTS EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Orthopaedic Chisel/Osteotome EUDAMEDOSTEOTOME CURVED 9mm x 13in FDA UDI
- Model / Reference
- TISSUE SPARING SOLUTIONS Orthopaedic Chisel/Osteotome EUDAMED6020-22-000 EUDAMEDFDA UDI
- Description
- OSTEOTOME CURVED 9mm x 13in FDA UDI
Identifiers
- Catalog Number
- 602022000 FDA UDI
- Primary DI / UDI-DI
- 10603295178484 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0049197 EUDAMED
- Direct Marketing DI
- 10603295178484 EUDAMED
- FDA Product Code
- HWM FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Depuy Orthopaedic Instruments by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0049197 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 244344e0-1348-4fb2-9565-10f1374cead5 61 fields · synced Jul 21, 2026
- FDA UDI 8a00f2b1-6fc9-4102-b6c1-5cf9547e66f8 35 fields · synced May 30, 2026