EXPRESSBRAID GRAFT MANIPULATION 110003463

GUDID 00880304566668

Biomet Orthopedics, LLC

Operative-site suture holder
Primary Device ID00880304566668
NIH Device Record Key2dcb1f79-9854-4aaa-8daa-fc4b8ceba739
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPRESSBRAID GRAFT MANIPULATION
Version Model Number110003463
Catalog Number110003463
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304566668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-06-11

On-Brand Devices [EXPRESSBRAID GRAFT MANIPULATION]

00880304566675110003464
00880304566668110003463

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