TI SCREW ES 902482

GUDID 00880304432109

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00880304432109
NIH Device Record Key18e815c8-1483-4f3b-a7cb-198e65b23164
Commercial Distribution StatusIn Commercial Distribution
Brand NameTI SCREW ES
Version Model Number902482
Catalog Number902482
Company DUNS627100159
Company NameBiomet Sports Medicine, 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
GS100880304432109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRSTAPLE, FIXATION, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2015-10-24

On-Brand Devices [TI SCREW ES]

00880304432109902482
00880304404380902579
00880304404373902578
00880304404359902576
00880304404335902574
00880304008434902556
00880304008298902554

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