Identity
- Trade Name
- PE – cup insert 10° FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 02804548 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844006952 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner 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: Constrained polyethylene acetabular liner
PE – cup insert 10° by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Constrained polyethylene acetabular liner.
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- Omnifit — Howmedica Osteonics Corp. · Class II
- G7® Freedom® Vivacit-E® — Zimmer, Inc. · Class II
- System 12 — Howmedica Osteonics Corp. · 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
- implantcast GmbH
Sources (1)
- FDA UDI e3a4bcd7-565a-4ed6-9063-dc06fe3992b7 33 fields · synced May 30, 2026