Identity
- Trade Name
- TEMA Elbow FDA UDI
- Generic Name
- Uncoated elbow humerus prosthesis FDA UDI
- Device Name
- Humeral Stem H6 right FDA UDI
- Model / Reference
- 1504.14.061 FDA UDI
- Description
- Humeral Stem H6 right FDA UDI
Identifiers
- Catalog Number
- 1504.14.061 FDA UDI
- Primary DI / UDI-DI
- 08033390140171 FDA UDI
- FDA Product Code
- JDB FDA UDIJDC FDA UDI
- GMDN Term
- Uncoated elbow humerus prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3160 FDA UDI888.3150 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
Category: Uncoated elbow humerus prosthesis
TEMA Elbow by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated elbow humerus prosthesis.
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- Total Elbow — Howmedica Osteonics Corp. · Class II
- Comprehensive® SRS / Discovery® — Biomet Orthopedics, Inc. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
- DISCOVERY-MOSAIC ELBOW SYSTEM — Biomet Orthopedics, Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI d6c70d07-bd50-4072-9794-0c3331a30c10 35 fields · synced May 30, 2026