Identity
- Trade Name
- GLOBAL UNITE FDA UDI
- Generic Name
- Reverse shoulder prosthesis body FDA UDI
- Device Name
- GLOBAL UNITE PLATFORM SHOULDER SYSTEM REVERSE FX EPI LEFT POROCOAT FDA UDI
- Model / Reference
- 1407-20-102 FDA UDI
- Description
- GLOBAL UNITE PLATFORM SHOULDER SYSTEM REVERSE FX EPI LEFT POROCOAT FDA UDI
Identifiers
- Catalog Number
- 140720102 FDA UDI
- Primary DI / UDI-DI
- 10603295446675 FDA UDI
- 510(k) Number
- K170748 FDA UDI
- FDA Product Code
- PHX FDA UDIHSD FDA UDIKWS FDA UDI
- GMDN Term
- Reverse shoulder prosthesis body FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Reverse shoulder prosthesis body
Global Unite by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis body.
- Duocentric® — Aston Medical · Class II
- BIO-MODULAR REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
- Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- Identity™ — Zimmer, Inc. · Class II
- Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- Duocentric® — Aston Medical · Class II
- Comprehensive® — Zimmer, Inc. · Class II
- Comprehensive® — Zimmer, Inc. · Class II
Cleared under the same submission
K170748 also covers:
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
- GLOBAL UNITE — DEPUY (IRELAND)
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI 8fcce7fa-806b-477d-a00b-0933dbe9ec9e 36 fields · synced May 30, 2026