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Global Advantage
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2128-65-050Model Humeral Head Trial Prosthesis
Identity
- Trade Name
- GLOBAL ADVANTAGE EUDAMEDFDA UDI
- Generic Name
- Humeral head prosthesis trial, reusable FDA UDI
- Device Name
- Humeral Head Trial Prosthesis EUDAMEDGLOBAL ADVANTAGE CUFF TEAR ARTHROPATHY(CTA) HEAD TRIAL 52mm x 18mm FDA UDI
- Model / Reference
- Humeral Head Trial Prosthesis EUDAMED2128-65-050 EUDAMEDFDA UDI
- Description
- GLOBAL ADVANTAGE CUFF TEAR ARTHROPATHY(CTA) HEAD TRIAL 52mm x 18mm FDA UDI
Identifiers
- Catalog Number
- 212865050 FDA UDI
- Primary DI / UDI-DI
- 10603295089933 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a000978X EUDAMED
- Direct Marketing DI
- 10603295089933 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Humeral head prosthesis trial, reusable 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 | 0603295a000978X | 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 ba2a13f1-3dc5-4862-9841-af04673f0670 61 fields · synced Jun 8, 2026
- FDA UDI 1095bb6c-9107-4fc0-9c5a-a03857ff643d 35 fields · synced May 27, 2026