T TAP HIP SYSTEM 12-165178

GUDID 00880304223554

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304223554
NIH Device Record Key8df2f08a-75cb-4f1b-bf8e-ef2621ce65d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameT TAP HIP SYSTEM
Version Model Number12-165178
Catalog Number12-165178
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
GS100880304223554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KMCProsthesis, hip, semi-constrained, composite/metal

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 [T TAP HIP SYSTEM]

0088030422355412-165178
0088030422354712-165174
0088030422353012-165170
0088030422352312-165166

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