Identity
- Trade Name
- GLOBAL ADVANTAGE FDA UDI
- Generic Name
- Humeral head prosthesis trial, reusable FDA UDI
- Device Name
- GLOBAL ADVANTAGE HUMERAL HEAD TRIAL 56mm x 18mm FDA UDI
- Model / Reference
- 2128-56-010 FDA UDI
- Description
- GLOBAL ADVANTAGE HUMERAL HEAD TRIAL 56mm x 18mm FDA UDI
Identifiers
- Catalog Number
- 212856010 FDA UDI
- Primary DI / UDI-DI
- 10603295089025 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Humeral head prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 Orthopaedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 608a2d13-56ff-4b0e-aa61-0a6d223fb3b1 36 fields · synced Jun 8, 2026