ALLTHREAD PEEK-OPTIMA 904922P

GUDID 00880304507098

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00880304507098
NIH Device Record Key413c73f4-de4f-46ec-b16b-e5c58b389f6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLTHREAD PEEK-OPTIMA
Version Model Number904922P
Catalog Number904922P
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
GS100880304507098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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

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