Premier™ 32-487265

GUDID 00887868496356

Biomet Orthopedics, LLC

Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable
Primary Device ID00887868496356
NIH Device Record Key43371a05-b601-4efc-8d8d-5d18874a6c7c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier™
Version Model Number32-487265
Catalog Number32-487265
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868496356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


[00887868496356]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-08

On-Brand Devices [Premier™]

0088786849638732-487268
0088786849637032-487267
0088786849636332-487266
0088786849635632-487265
0088786849634932-487264
0088786849633232-487263
0088786849632532-487262
0088786849631832-487261
0088786849630132-487260

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Mark Image

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