BIOMET SERIES A ASYMMETRIC 32-486545

GUDID 00880304612617

Biomet Orthopedics, LLC

Patella prosthesis trial

• Primary Device ID: 00880304612617
• NIH Device Record Key: c7bbf75c-b21b-4197-8b4a-cc2bcd59f2b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET SERIES A ASYMMETRIC
• Version Model Number: 32-486545
• Catalog Number: 32-486545
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304612617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110362

FDA Product Code

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

Sterilization

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

[00880304612617]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-30
• Device Publish Date: 2016-10-25

On-Brand Devices [BIOMET SERIES A ASYMMETRIC]

• 00880304612648: 32-486548
• 00880304612631: 32-486547
• 00880304612624: 32-486546
• 00880304612617: 32-486545
• 00880304612600: 32-486544
• 00880304612594: 32-486543