Identity
- Trade Name
- SUNFIT TH FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- NOVAE Dual Mobility Acetabular Cup - SUNFIT TH metal-back cementless SUNFIT TH version is available without the pegs and screw, and is a press fit only FDA UDI
- Model / Reference
- SUNFIT TH 63 FDA UDI
- Description
- NOVAE Dual Mobility Acetabular Cup - SUNFIT TH metal-back cementless SUNFIT TH version is available without the pegs and screw, and is a press fit only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662200005482 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetabular shell
Sunfit Th by Soc Etudes Recherches Fabrication — 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
- Soc Etudes Recherches Fabrication
Sources (1)
- FDA UDI c4bfa6e8-c350-43d6-b5ef-bb38b35429dd 33 fields · synced Jun 1, 2026