BC Reflex Uni 018-001

GUDID 00688346002072

Laboratoires Bodycad Inc

Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis

• Primary Device ID: 00688346002072
• NIH Device Record Key: b126aab1-a0cf-4821-92a3-5ffa44d2fd19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BC Reflex Uni
• Version Model Number: 018-001
• Catalog Number: 018-001
• 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: true
• 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	00688346000061 [Previous]
GS1	00688346002072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191996

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-16
• Device Publish Date: 2021-06-08

On-Brand Devices [BC Reflex Uni ]

• 62845195000066: 018-001
• 00688346000061: 018-001
• 00688346002072: 018-001
• 00688346001358: 018-001
• 00688346001341: 018-001
• 00688346001334: 018-001
• 00688346001204: 018-001