COMPREHENSIVE(R) SHOULDER SYSTEM 406995

GUDID 00880304367005

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00880304367005
NIH Device Record Key0995f675-f31c-4f4b-83c3-b6aad0b56a2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE(R) SHOULDER SYSTEM
Version Model Number406995
Catalog Number406995
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100880304367005 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304367005]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2017-07-28

On-Brand Devices [COMPREHENSIVE(R) SHOULDER SYSTEM]

0088030443190431-406901
00880304367029406997
00880304367005406995
00880304009592406994

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