AGC REVISION KNEE 154547

GUDID 05019279387816

Biomet Uk Ltd

Knee arthroplasty wedge

• Primary Device ID: 05019279387816
• NIH Device Record Key: 55efef47-5d52-4a3f-9a89-80694b5f2c5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGC REVISION KNEE
• Version Model Number: 154547
• Catalog Number: 154547
• Company DUNS: 219322575
• Company Name: Biomet Uk Ltd
• 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.c

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019279387816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984054

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [AGC REVISION KNEE]

• 05019279387854: 154554
• 05019279387830: 154552
• 05019279387816: 154547
• 05019279387793: 154545
• 05019279387786: 154544
• 05019279387779: 154540
• 05019279387748: 154537
• 05019279387700: 154530