UNIFLEX SYSTEM 33-345534

GUDID 00880304352605

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00880304352605
NIH Device Record Key7ac7e86a-1c69-45c7-8b10-7af69242cd92
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFLEX SYSTEM
Version Model Number33-345534
Catalog Number33-345534
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Datefalse
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)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304352605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [UNIFLEX SYSTEM]

00880304529823344265
00880304529816344380
00880304529809344075
00880304529793344375
00880304529786344170
00880304529144344365
00880304529137344165
00880304523487344065
00880304522169344070
00880304522091344275
00880304521773344470
00880304516052344060
00880304511613344270
00880304511316344160
00880304511279344480
00880304507845344280
00880304507708344465
00880304507692344370
00880304491205344175
00880304489516344475
00880304357594345296
00880304357587345294
00880304357280345211
0088030435268133-345548
0088030435267433-345546
0088030435266733-345544
0088030435265033-345542
0088030435264333-345540
0088030435262933-345538
0088030435261233-345536
0088030435260533-345534
0088030435258233-345532
0088030435257533-345530
0088030435256833-345528
0088030435254433-345526
0088030435252033-345524
0088030435250633-345522
0088030435248333-345520
00888480285588344180
00888480285434344080

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