BI-MENTUM PE Liner

FDA UDI

Class II (US FDA UDI)

by Soc Etudes Recherches Fabrication

Identity

Trade Name: BI-MENTUM PE Liner FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner FDA UDI
Model / Reference: BI-MENTUM PE Liner 28 / 51 FDA UDI
Description: BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner FDA UDI

Identifiers

Primary DI / UDI-DI: 03662200015665 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
GMDN Term: Non-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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Non-constrained polyethylene acetabular liner

BI-MENTUM PE Liner by Soc Etudes Recherches Fabrication — 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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G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
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: Soc Etudes Recherches Fabrication

Sources (1)

FDA UDI 12e6ffa3-2dc9-4be9-ad61-8dd2d6e4e47f 33 fields · synced May 31, 2026