MAX-TI ACETABULAR 124090

GUDID 00880304225497

Biomet Orthopedics, LLC

Orthopaedic fixation implant alignment tool
Primary Device ID00880304225497
NIH Device Record Key16b8fc49-fbb0-4eb2-a067-28b9ba7c22c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-TI ACETABULAR
Version Model Number124090
Catalog Number124090
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
GS100880304225497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304225497]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [MAX-TI ACETABULAR]

0088030430130631-105848
0088030430129031-105844
0088030430005731-104395
00880304225695124196
00880304225688124195
00880304225671124194
00880304225664124193
00880304225657124192
00880304225640124191
00880304225633124190
00880304225527124093
00880304225510124092
00880304225497124090
00880304225541124095
00880304225534124094
00880304225503124091

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