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Depuy Orthopaedic Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1299-01-054Model SIGMA Instrument Handle, Knee
Identity
- Trade Name
- DEPUY ORTHOPAEDIC INSTRUMENTS EUDAMEDNA FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Instrument Handle, Knee EUDAMEDCAS Ligament Tensor Handle FDA UDI
- Model / Reference
- SIGMA Instrument Handle, Knee EUDAMED1299-01-054 EUDAMEDFDA UDI
- Description
- CAS Ligament Tensor Handle FDA UDI
Identifiers
- Catalog Number
- 129901054 FDA UDI
- Primary DI / UDI-DI
- 10603295026914 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004008A EUDAMED
- Direct Marketing DI
- 10603295026914 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 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 | 0603295a004008A | 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 a6fe40c5-3c53-41f0-bbca-6c420a645b9c 61 fields · synced Jul 20, 2026
- FDA UDI 890f1343-13c2-49cf-97b6-0684c534a144 35 fields · synced May 30, 2026