GUDID 00889024301856

Reamer for humeral stem 12

Zimmer GmbH

Joint prosthesis implantation kit, reusable
Primary Device ID00889024301856
NIH Device Record Key2aaf862d-182b-44aa-9e3f-5278e5c2b8aa
Commercial Distribution StatusIn Commercial Distribution
Version Model Number72.02.20-12
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 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
GS100889024301856 [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

[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


[00889024301856]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2016-09-24

Devices Manufactured by Zimmer GmbH

00889024292512 - NCB®2024-05-13
00889024292550 - NCB®2024-05-13
00889024296558 - NCB®2024-05-13
00889024296565 - NCB®2024-05-13
00889024296572 - NCB®2024-05-13
00889024593152 - Wagner Cone Prosthesis®2023-12-20
00889024593176 - Wagner Cone Prosthesis®2023-12-20
00889024593183 - Wagner Cone Prosthesis®2023-12-20

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