BIOMET 360 32-360137

GUDID 00880304495920

Biomet Orthopedics, LLC

Knee tibia prosthesis trial
Primary Device ID00880304495920
NIH Device Record Keycecc988a-f9e7-4516-88f0-ad0c3ce74b65
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMET 360
Version Model Number32-360137
Catalog Number32-360137
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
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 Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304495920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBVProsthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


[00880304495920]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-21

On-Brand Devices [BIOMET 360]

0088030450230732-360134
0088030450223932-360133
0088030450219232-360132
0088030450218532-360135
0088030450217832-360136
0088030449614932-360138
0088030449592032-360137
0088030449551732-360125
0088030449550032-360126
0088030449545632-360122
0088030449544932-360128
0088030449543232-360120
0088030449542532-360127
0088030449534032-360131
0088030449532632-360121
0088030449529632-360130
0088030449423732-360124
0088030449418332-360123

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