Identity
- Trade Name
- TEMA Elbow System FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Flexible Reamer # 3 FDA UDI
- Model / Reference
- 9CC0.95.086 FDA UDI
- Description
- Flexible Reamer # 3 FDA UDI
Identifiers
- Catalog Number
- 9CC0.95.086 FDA UDI
- Primary DI / UDI-DI
- 08033390151252 FDA UDI
- FDA Product Code
- JDB FDA UDIJDC FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3160 FDA UDI888.3150 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
TEMA Elbow System by Limacorporate — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI a0596887-83ae-48be-a5cc-f8aabfd7fc14 36 fields · synced May 30, 2026