G7 PROVISIONAL HIGH WALL LINER 010002664

GUDID 00880304565968

Biomet Orthopedics, LLC

Acetabulum prosthesis trial, reusable
Primary Device ID00880304565968
NIH Device Record Keyf0831578-e5d7-4fa9-bd2a-b5f9fa606dd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7 PROVISIONAL HIGH WALL LINER
Version Model Number010002664
Catalog Number010002664
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304565968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


[00880304565968]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-07
Device Publish Date2016-09-22

On-Brand Devices [G7 PROVISIONAL HIGH WALL LINER]

00880304566033010002678
00880304566026010002676
00880304566019010002675
00880304566002010002670
00880304565999010002667
00880304565982010002666
00880304565975010002665
00880304565968010002664
00880304565951010002663
00880304565944010002660
00880304565937010002659
00880304565920010002658
00880304565913010002657
00880304565906010002656
00880304565883010002653
00880304565876010002652
00880304565869010002651
00880304565852010002650
00880304565845010002649
00880304565838010002648
00880304565821010002647
00880304553866010002677
00880304551862010002655
00880304551855010002645
00880304551848010002646
00880304551770010002674
00880304551763010002673
00880304551640010002672
00880304551633010002671
00880304551480010002668
00880304551459010002669
00880304551343010002662
00880304551282010002661

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.