COMPREHENSIVE SHOULDER INSTRUMENTS 406920

GUDID 00880304540187

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00880304540187
NIH Device Record Key04a35ae8-abbb-475a-899a-2ff8bef30b61
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE SHOULDER INSTRUMENTS
Version Model Number406920
Catalog Number406920
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304540187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


[00880304540187]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-10-28

Devices Manufactured by Biomet Orthopedics, LLC

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00889024684317 - Juggerknot Reusable Fishmouth Guide2025-01-21
00889024685604 - Jgrknt Reusable Fishmouth Curved Perc Guide2025-01-21
00887868254451 - Comprehensive® Reverse Shoulder2024-11-21
00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11

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