BIO-MODULAR REVERSE SHOULDER 11-113680

GUDID 00880304591219

Biomet Orthopedics, LLC

Reverse shoulder prosthesis body
Primary Device ID00880304591219
NIH Device Record Keybc312677-3b79-4677-8991-8f3340005e9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-MODULAR REVERSE SHOULDER
Version Model Number11-113680
Catalog Number11-113680
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304591219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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 [BIO-MODULAR REVERSE SHOULDER]

0088030459121911-113680
0088030450693011-113685
00880304562646595550

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