Identity
- Trade Name
- INSERT CC 32X58 FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 10078 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209100780 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-constrained polyethylene acetabular liner
Insert Cc 32x58 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
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- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
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
- Biopro, Inc.
Sources (1)
- FDA UDI 5597f3ed-7a8b-40e6-aba4-73d74a7bfee5 32 fields · synced Jun 1, 2026