Bodycad Unicompartmental Knee System 010003

GUDID 00688346010008

Laboratoires Bodycad Inc

Unicondylar knee prosthesis

• Primary Device ID: 00688346010008
• NIH Device Record Key: c7f261c8-ccc8-4f36-bcd2-5bfecce4f136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bodycad Unicompartmental Knee System
• Version Model Number: 010003
• Catalog Number: 010003
• Company DUNS: 202981171
• Company Name: Laboratoires Bodycad Inc
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00688346010008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163700

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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: 2020-05-14
• Device Publish Date: 2017-04-13

On-Brand Devices [Bodycad Unicompartmental Knee System]

• 62845195010003: 010003
• 00688346010008: 010003