Identity
- Trade Name
- INHANCE FDA UDI
- Generic Name
- Reverse shoulder head prosthesis trial FDA UDI
- Device Name
- INHANCE SHOULDER SYSTEM GLENOSPHERE TRIAL ECCENTRIC Ø40 +4mm FDA UDI
- Model / Reference
- 6505-40-104 FDA UDI
- Description
- INHANCE SHOULDER SYSTEM GLENOSPHERE TRIAL ECCENTRIC Ø40 +4mm FDA UDI
Identifiers
- Catalog Number
- 650540104 FDA UDI
- Primary DI / UDI-DI
- 10603295547563 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Reverse shoulder head prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- 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
Category: Reverse shoulder head prosthesis trial
Inhance by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder head prosthesis trial.
- Equinoxe — Exactech, Inc. · Class I
- ProMade Shoulder — Limacorporate · Class I
- AGILON® XO trial glenosphere — implantcast GmbH · Class II
- AGILON® XO trial cap inverse — implantcast GmbH · Class II
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- SMR Shoulder - Hybrid Glenoid — Limacorporate · Class II
- REUNION — Stryker Corp. · Class II
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 (ireland)
Sources (1)
- FDA UDI c95ff9cb-24ed-4463-8301-9f9b4eaf8de9 35 fields · synced Jun 8, 2026