AGC V2 HPS TOTAL KNEE SYSTEM RD180012

GUDID 00880304149786

Biomet Orthopedics, LLC

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00880304149786
• NIH Device Record Key: d81e8b34-5f93-4571-8810-d98b111b91e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGC V2 HPS TOTAL KNEE SYSTEM
• Version Model Number: RD180012
• Catalog Number: RD180012
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00880304149786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833921

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-24

On-Brand Devices [AGC V2 HPS TOTAL KNEE SYSTEM]

• 00880304149809: RD180014
• 00880304149793: RD180013
• 00880304149786: RD180012
• 00880304149779: RD180011
• 00880304149762: RD180010