Identity
- Trade Name
- INSTRUMENT FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- RESTORATION ANATOMIC SHELL TRIAL FDA UDI
- Model / Reference
- 2208-6053L FDA UDI
- Description
- RESTORATION ANATOMIC SHELL TRIAL FDA UDI
Identifiers
- Catalog Number
- 2208-6053L FDA UDI
- Primary DI / UDI-DI
- 07613327012118 FDA UDI
- FDA Product Code
- KWZ FDA UDILZO FDA UDIJDI FDA UDILWJ FDA UDIMAY FDA UDIKWY FDA UDIHWC FDA UDIKWL FDA UDIMBL FDA UDILPH FDA UDIMEH FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 FDA UDI888.3353 FDA UDI888.3350 FDA UDI888.3360 FDA UDI888.3390 FDA UDI888.3040 FDA UDI888.3358 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Outer Diameter — 53.0 Millimeter FDA UDI
Category: Acetabulum prosthesis trial, prefabricated, reusable
Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI f30a55ad-3028-46f9-9232-2e87e3f03d55 35 fields · synced Jun 6, 2026