COMPREHENSIVE INSTRUMENTATION 110028438

GUDID 00880304731325

Biomet Orthopedics, LLC

Surgical torque wrench, reusable
Primary Device ID00880304731325
NIH Device Record Keya126ca20-03ee-4382-b077-c52d97e1a11a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE INSTRUMENTATION
Version Model Number110028438
Catalog Number110028438
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304731325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304731325]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-17
Device Publish Date2017-07-28

On-Brand Devices [COMPREHENSIVE INSTRUMENTATION]

00880304731752110016882
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00880304731509110028880
00880304731394110028879
00880304731387110028878
00880304731332110028439
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00880304716209110016888
00880304716193110016887
00880304716186110016886
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00880304716155110016883
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