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Global Advantage
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2128-61-030Model Shoulder Glenoid Fossa Prosthesis Trial
Identity
- Trade Name
- GLOBAL ADVANTAGE EUDAMEDFDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis trial FDA UDI
- Device Name
- Shoulder Glenoid Fossa Prosthesis Trial EUDAMEDGLOBAL ADVANTAGE FINNED GLENOID TRIAL 56mmXL FDA UDI
- Model / Reference
- Shoulder Glenoid Fossa Prosthesis Trial EUDAMED2128-61-030 EUDAMEDFDA UDI
- Description
- GLOBAL ADVANTAGE FINNED GLENOID TRIAL 56mmXL FDA UDI
Identifiers
- Catalog Number
- 212861030 FDA UDI
- Primary DI / UDI-DI
- 10603295089520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001017V EUDAMED
- Direct Marketing DI
- 10603295089520 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Shoulder glenoid fossa prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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 IIa — 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 | 0603295a001017V | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 2448ee1f-a303-4648-b2ce-62f6c92554a3 61 fields · synced May 30, 2026
- FDA UDI 1d985861-63c1-425a-a77f-201a5930860e 35 fields · synced May 30, 2026