Anatomical Shoulder#

GUDID 00889024286245

A.S. Ball-taper for Humeral stems

Zimmer GmbH

Total shoulder prosthesis
Primary Device ID00889024286245
NIH Device Record Keyd3b04839-0d5b-4846-950f-6a6eb88b643b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomical Shoulder#
Version Model Number01.04227.102
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024286245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2015-10-16

On-Brand Devices [Anatomical Shoulder#]

00889024286306AS Humeral head FX right 48
00889024286290AS Humeral head FX left 48
00889024286283AS Humeral head FX right 44
00889024286276AS Humeral head FX left 44
00889024286269AS Humeral head FX right 40
00889024286252AS Humeral head FX left 40
00889024286245A.S. Ball-taper for Humeral stems
00889024285965AS Humeral stem FX 13-200
00889024285958AS Humeral stem FX 11-200
00889024285941AS Humeral stem FX 9-200
00889024285934AS Humeral stem FX 7-170
00889024285910A.S. Humeral stem Rev. 12 cemented
00889024285903A.S. Humeral stem Rev. 9 cemented
00889024285897A.S. Humeral stem Rev. 7 cem.
00889024285798A.S. Humeral head D 52 H 19
00889024285682AS Humeral stem FX 14-130
00889024285675AS Humeral stem FX 13-130
00889024285668AS Humeral stem FX 12-130
00889024285651AS Humeral stem FX 11-130
00889024285644AS Humeral stem FX 10-130
00889024285637AS Humeral stem FX 9-130
00889024285620AS Humeral stem FX 8-130
00889024285613AS Humeral stem FX 7-130
00889024285569A.S. Humeral stem 7 uncemented

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