BIO-MODULAR / BI-POLAR SHOULDER 113143

GUDID 00880304003958

Biomet Orthopedics, LLC

Bipolar partial shoulder prosthesis
Primary Device ID00880304003958
NIH Device Record Keybeda8f55-b245-4bbe-8e96-dc74f1c64aa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-MODULAR / BI-POLAR SHOULDER
Version Model Number113143
Catalog Number113143
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 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
GS100880304003958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJTPROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-17
Device Publish Date2015-10-24

On-Brand Devices [BIO-MODULAR / BI-POLAR SHOULDER]

00880304212411113147
00880304212398113144
00880304007802113145
00880304003958113143
00880304002388113146

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.