Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- ANTEROLAT DIST TIB PLT, SS, LEFT, 11H FDA UDI
- Model / Reference
- AR-8963AL-11 FDA UDI
- Description
- ANTEROLAT DIST TIB PLT, SS, LEFT, 11H FDA UDI
Identifiers
- Catalog Number
- AR-8963AL-11 FDA UDI
- Primary DI / UDI-DI
- 00888867223080 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Arthrex® by Arthrex, 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
- Arthrex, Inc.
Sources (1)
- FDA UDI 4a4a004c-9065-4332-9410-312fa97ce770 36 fields · synced May 31, 2026