Identity
- Trade Name
- Made-To-Order FDA UDI
- Generic Name
- Glenoid orthopaedic reamer FDA UDI
- Device Name
- Affiniti Humeral Reamer FDA UDI
- Model / Reference
- 9028803 FDA UDI
- Description
- Affiniti Humeral Reamer FDA UDI
Identifiers
- Catalog Number
- 9028803 FDA UDI
- Primary DI / UDI-DI
- 00840338601483 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Glenoid orthopaedic reamer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
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
Made-To-Order by Tornier, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 12c73fa3-9fc9-4f0b-a287-4d077cb2254c 37 fields · synced May 31, 2026