Identity
- Trade Name
- Affiniti™ PC FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Model / Reference
- 1122231 FDA UDI
Identifiers
- Catalog Number
- 1122231 FDA UDI
- Primary DI / UDI-DI
- 00846832003051 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Coated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 16 Millimeter FDA UDILength — 110 Millimeter FDA UDI
Affiniti™ PC by Tornier, Inc. — 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 |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 4613ae4b-0945-42fc-985a-c7ed380f9c74 36 fields · synced Jun 6, 2026