BIOMET KNEE 32-341637

GUDID 00880304536821

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304536821
• NIH Device Record Key: 720997db-a2f5-4f04-9a71-08cde1794ba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET KNEE
• Version Model Number: 32-341637
• Catalog Number: 32-341637
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304536821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121149

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

[00880304536821]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-21

On-Brand Devices [BIOMET KNEE]

• 00880304541313: 32-341617
• 00880304537019: 32-148153
• 00880304536999: 32-341619
• 00880304536982: 32-148147
• 00880304536975: 32-341639
• 00880304536968: 32-148149
• 00880304536951: 32-148151
• 00880304536913: 32-341621
• 00880304536845: 32-341623
• 00880304536821: 32-341637
• 00880304459632: 32-341640
• 00880304459625: 32-341638
• 00880304459618: 32-341636
• 00880304459601: 32-341634
• 00880304459595: 32-341632
• 00880304453098: 32-148140
• 00880304453081: 32-148148
• 00880304453074: 32-148150
• 00880304453067: 32-148142
• 00880304453050: 32-148152
• 00880304453043: 32-148146
• 00880304453036: 32-148154
• 00880304453029: 32-148144
• 00880304324534: 32-341620
• 00880304324527: 32-341612
• 00880304324510: 32-341610
• 00880304011397: 32-341624
• 00880304011380: 32-341622
• 00880304008953: 32-341616
• 00880304008946: 32-341614
• 00880304000438: 32-341618