ANATOMICAL SHOULDER™ DOMELOCK®

GUDID 00889024275812

Trial T-Dome 129L00 / 141R00 - centric

Zimmer GmbH

Humeral head prosthesis trial, reusable
Primary Device ID00889024275812
NIH Device Record Key0abc778f-38fd-4a1b-9569-da957b706be1
Commercial Distribution StatusIn Commercial Distribution
Brand NameANATOMICAL SHOULDER™ DOMELOCK®
Version Model Number01.04558.222
Company DUNS488133448
Company NameZimmer GmbH
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)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024275812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


[00889024275812]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-14
Device Publish Date2016-09-24

On-Brand Devices [ANATOMICAL SHOULDER™ DOMELOCK®]

0088902448529701.04212.505
0088902448528001.04212.485
0088902448500601.04227.005
0088902448046901.04213.565
0088902448045201.04212.565
0088902448044501.04213.545
0088902448043801.04212.545
0088902448042101.04213.525
0088902448041401.04212.525
0088902448040701.04213.505
0088902448039101.04213.485
0088902448038401.04213.465
0088902448037701.04212.465
0088902448036001.04213.445
0088902448035301.04212.445
0088902448034601.04213.425
0088902448033901.04212.425
0088902448032201.04213.405
0088902448031501.04212.405
0088902448030801.04213.385
0088902448029201.04212.385
0088902448028501.04213.365
0088902448027801.04212.365
0088902448064301.04227.229
0088902448060501.04227.219
0088902448057501.04227.233
0088902448048301.04227.215
0088902448069801.04227.227
0088902448068101.04227.232
0088902448067401.04227.217
0088902448066701.04227.222
0088902448062901.04227.234
0088902448059901.04227.224
0088902448058201.04227.228
0088902448056801.04227.218
0088902448055101.04227.223
0088902448054401.04227.226
0088902448053701.04227.231
0088902448052001.04227.216
0088902448051301.04227.221
0088902448050601.04227.225
0088902448049001.04227.230
0088902448047601.04227.220
00889024387195Trial Head 40-17
00889024387188Trial Head 40-14
00889024276031Rasp adapter
00889024276024Angle Identification Card right
00889024276017Angle Identification Card left
00889024276000Trial T-Dome 132R10 / 138L10 - eccentric
00889024275997Trial T-Dome 132L10 / 138R10 - eccentric

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