Identity
- Trade Name
- EXp Acetabular Shell and Liner FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Device Name
- 32 MM EXp Hooded Liner FDA UDI
- Model / Reference
- SC3345-32-5052 FDA UDI
- Description
- 32 MM EXp Hooded Liner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840843109181 FDA UDI
- FDA Product Code
- OQG FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
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: Constrained polyethylene acetabular liner
EXp Acetabular Shell and Liner by Globus Medical, Inc. — 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
- Globus Medical, Inc.
Sources (1)
- FDA UDI 0f5d6939-0e85-4589-9820-3a708d149d02 33 fields · synced May 31, 2026