GUDID 00889024106680

Zimmer GmbH

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00889024106680
NIH Device Record Key1c60a862-fb33-45bd-8aea-1d1a2b3f76eb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number22.28.512
Company DUNS488133448
Company NameZimmer GmbH
Device Count6
DM Exempttrue
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 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@zimmer.com

Device Dimensions

Length150 Millimeter
Outer Diameter1.2 Millimeter
Device Size Text, specify0
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024106680 [Primary]
GS100889024491700 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024106680]

Moist Heat or Steam Sterilization


[00889024106680]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-30

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

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