G7 110010303

GUDID 00880304700284

Biomet Orthopedics, LLC

Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable
Primary Device ID00880304700284
NIH Device Record Key099cd6bb-0348-4f10-9147-9c77a45c1915
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7
Version Model Number110010303
Catalog Number110010303
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
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
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Device Size Text, specify0
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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 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
GS100880304700284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


[00880304700284]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-23

On-Brand Devices [G7]

00880304849297SSI003162
00880304849280SSI003161
00880304700307110010305
00880304700291110010304
00880304700284110010303
00880304700277110010302
00880304700260110010301
00880304700253110010300
00880304700147110017241
00880304700130110017240
00880304682429110017403
00880304682412110017402
00880304682405110017266
00880304682399110017265
00880304682382110017264
00880304682375110017263
00880304682368110017262
00880304682351110017261
00880304682344110017260
00880304682337110017259
00880304682320110017258
00880304682313110017257
00880304682306110017256
00880304682290110017255
00880304682283110017254
00880304682276110017253
00880304682269110017252
00880304682245110017250
00880304682238110017249
00880304682221110017248
00880304682214110017247
00880304682207110017246
00880304682191110017245
00880304682184110017244
00880304682177110017243
00880304682160110017239
00880304682153110017238
00880304682146110017237
00880304682139110017236
00880304682122110017235
00880304682115110017234
00880304682108110017233
00880304682092110010314
00880304682085110010313
00880304682078110010312
00880304682061110010311
00880304682054110010310
00880304682047110010309
00880304682030110010308
00880304682023110010307

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