Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- CUP,ACETABULAR, HOODED ALL-POLY 52X28 FDA UDI
- Model / Reference
- 400-02-052 FDA UDI
- Description
- CUP,ACETABULAR, HOODED ALL-POLY 52X28 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912075817 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetabular shell
Djo Surgical by Djo, Llc — 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
- Djo, Llc
Sources (1)
- FDA UDI 9535dfe9-63a9-4614-b618-f644478c98ca 33 fields · synced Jun 8, 2026