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Global Advantage
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2128-23-000Model Orthopaedic Osteotome
Identity
- Trade Name
- GLOBAL ADVANTAGE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Orthopaedic Osteotome EUDAMEDGLOBAL ADVANTAGE COOKIE CUTTER 12mm FDA UDI
- Model / Reference
- Orthopaedic Osteotome EUDAMED2128-23-000 EUDAMEDFDA UDI
- Description
- GLOBAL ADVANTAGE COOKIE CUTTER 12mm FDA UDI
Identifiers
- Catalog Number
- 212823000 FDA UDI
- Primary DI / UDI-DI
- 10603295088547 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004258S EUDAMED
- Direct Marketing DI
- 10603295088547 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
Global Advantage 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 | 0603295a004258S | 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 cbbfff95-a3b3-4046-ad14-08c7f046a189 61 fields · synced May 30, 2026
- FDA UDI 765a2997-1d09-46bd-8e9f-9a0838481db0 35 fields · synced May 30, 2026