Identity
- Trade Name
- BI-MENTUM Plus Cup FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- BI-MENTUM dual mobility system - BI-MENTUM Plus Cup metal-back cementless BI-MENTUM Plus Cup has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium) FDA UDI
- Model / Reference
- BI-MENTUM Plus Cup 45 FDA UDI
- Description
- BI-MENTUM dual mobility system - BI-MENTUM Plus Cup metal-back cementless BI-MENTUM Plus Cup has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662200015115 FDA UDI
- FDA Product Code
- MEH FDA UDILZO 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
BI-MENTUM Plus Cup 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 cc7b5aa9-dbac-4228-86b6-99c1a69328ed 33 fields · synced Jun 1, 2026