BI-MENTUM Cemented Cup

GUDID 03662200015405

BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented

SOC ETUDES RECHERCHES FABRICATION

Acetabular shell
Primary Device ID03662200015405
NIH Device Record Keyef2b6aa7-0965-4e17-b211-522fc28071e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-MENTUM Cemented Cup
Version Model NumberBI-MENTUM Cemented Cup 47
Company DUNS282651413
Company NameSOC ETUDES RECHERCHES FABRICATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103662200015405 [Primary]

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-09
Device Publish Date2019-01-15

On-Brand Devices [BI-MENTUM Cemented Cup]

03662200015481BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015474BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015467BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015450BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015443BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015436BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015429BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015412BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015405BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015399BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented
03662200015382BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented

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