BC Reflex Uni 018-001

GUDID 00688346001334

Laboratoires Bodycad Inc

Unicondylar knee prosthesis

• Primary Device ID: 00688346001334
• NIH Device Record Key: 5a9b7b1a-c63e-445f-9717-f5bc1c5f3a46
• 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	00688346001334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212307

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: 2021-12-22
• Device Publish Date: 2021-12-13

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