Identity
- Trade Name
- GLOBAL FX FDA UDI
- Generic Name
- Humeral stem prosthesis trial, reusable FDA UDI
- Device Name
- GLOBAL FX STEM TRIAL 6mm FDA UDI
- Model / Reference
- 2128-06-000 FDA UDI
- Description
- GLOBAL FX STEM TRIAL 6mm FDA UDI
Identifiers
- Catalog Number
- 212806000 FDA UDI
- Primary DI / UDI-DI
- 10603295088202 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Humeral stem 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 Fx 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 07e0bcac-7480-4470-bcfa-47ff996e4e77 36 fields · synced Jun 8, 2026