G7® 010002719

GUDID 00887868461811

Biomet Orthopedics, LLC

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor
Primary Device ID00887868461811
NIH Device Record Key0d6f0b9b-67dd-40f0-834e-4c3ca434dda9
Commercial Distribution StatusIn Commercial Distribution
Brand NameG7®
Version Model Number010002719
Catalog Number010002719
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100887868461811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


[00887868461811]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-28
Device Publish Date2021-05-20

On-Brand Devices [G7®]

00887868413049010002736
00880304652101XRAY000162
00887868460746010002533
00887868460739010002532
00887868460722010002531
00887868460715010002530
00887868460708010002519
00887868460692010002518
00887868460685010002517
00887868460678010002516
00887868460661010002515
00887868460654010002514
00887868460647010002513
00887868460630010002512
00887868460623010002511
00887868460616010002510
00887868460609010002509
00887868460593010002508
00887868460586010002507
00887868460579010002506
00887868460562010002505
00887868460555010002504
00887868460548010002503
00887868460531010002502
00887868460524010002501
00887868460517010002500
00887868460500010002499
00887868460494010002498
00887868460487010002497
00887868460470010002496
00887868460463010002495
00887868460456010002494
00887868460449010002493
00887868460432010002492
00887868460425010002491
00887868460418010002490
00887868460401010002489
00887868460395010002488
00887868460388010002487
00887868460371010002486
00887868460364010002485
00887868460357010002481
00887868460340010002480
00887868460333010002479
00887868460326010002478
00887868460319010002477
00887868460302010002476
00887868460296010002475
00887868460289010002474
00887868460272010002473

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