00-0186-004-53

GUDID 00889024021808

Zimmer, Inc.

Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID00889024021808
NIH Device Record Key20678535-5140-4556-9271-85e83e1bf1ba
Commercial Distribution StatusIn Commercial Distribution
Version Model Number186-04-53
Catalog Number00-0186-004-53
Company DUNS056038268
Company NameZimmer, Inc.
Device Count6
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 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@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Length3 Inch
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024021808 [Primary]
GS100889024409422 [Unit of Use]

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024021808]

Moist Heat or Steam Sterilization


[00889024021808]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2015-09-24

Devices Manufactured by Zimmer, Inc.

00889024648180 - ROSA® Shoulder2024-02-29
00889024648197 - ROSA® Shoulder2024-02-29
00889024648203 - ROSA® Shoulder2024-02-29
00889024625877 - G7 25MM DRILL GUIDE2023-12-25
00889024657441 - RDCTN HNDL ASSY LRG2023-12-25
00889024658004 - PIVOTING HUMERAL EM GUIDE2023-12-25
00889024660571 - 3.5MM BALL HEX SHAFT2023-12-25
00889024661257 - REAMER ADPT PULLER2023-12-25

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