COMPREHENSIVE(R) SHOULDER SYSTEM 31-406901

GUDID 00880304431904

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting
Primary Device ID00880304431904
NIH Device Record Key0319886f-9470-44b4-a90f-98ca37ecf09c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE(R) SHOULDER SYSTEM
Version Model Number31-406901
Catalog Number31-406901
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
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
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
GS100880304431904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


[00880304431904]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2017-07-28

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

0088030443190431-406901
00880304367029406997
00880304367005406995
00880304009592406994

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