BIOMET(R) 32-467355

GUDID 00880304339354

Biomet Orthopedics, LLC

Patella prosthesis trial

• Primary Device ID: 00880304339354
• NIH Device Record Key: 283d8a39-1e17-4962-ac2d-9438b98575fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET(R)
• Version Model Number: 32-467355
• Catalog Number: 32-467355
• 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
• 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
• 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 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 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	00880304339354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

Moist Heat or Steam Sterilization

[00880304339354]

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(R)]

• 00880304339378: 32-467360
• 00880304339361: 32-467358
• 00880304339354: 32-467355
• 00880304002302: 32-467356