TAPERLOC COMPLETE 51-200000

GUDID 00880304481046

Biomet Orthopedics, LLC

Femoral stem prosthesis trial
Primary Device ID00880304481046
NIH Device Record Keyedffbb83-93c7-48d1-99dc-ee3e90549050
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAPERLOC COMPLETE
Version Model Number51-200000
Catalog Number51-200000
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
GS100880304481046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304481046]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-30
Device Publish Date2016-09-22

On-Brand Devices [TAPERLOC COMPLETE]

0088030454600451-206220
0088030454599151-206240
0088030454133751-206200
0088030453212051-222225
0088030452077651-206180
0088030452076951-208040
0088030452014151-208080
0088030451971851-208070
0088030451970151-208050
0088030451969551-208060
0088030451686151-206130
0088030451685451-206100
0088030451684751-206140
0088030451683051-206120
0088030451682351-206160
0088030451681651-206090
0088030451680951-206110
0088030451679351-206170
0088030451678651-206150
0088030450972651-222223
0088030450678751-201040
0088030449708551-201060
0088030449707851-201050
0088030448104651-200000
0088030448096451-201070
0088030448095751-201080
0088030448094051-201170
0088030448092651-201150
0088030448090251-201120
0088030448089651-201130

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