BC Reflex Uni Reusable Surgical Instrument Set 027-003

GUDID 00688346002478

Reusable Surgical Instrument Set

Laboratoires Bodycad Inc

Unicondylar knee prosthesis

• Primary Device ID: 00688346002478
• NIH Device Record Key: 2e8cd6c0-d57e-4f71-b391-a614ee7eb771
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BC Reflex Uni Reusable Surgical Instrument Set
• Version Model Number: 027-003
• Catalog Number: 027-003
• 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: false
• 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	00688346002478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211646

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

[00688346002478]

Moist Heat or Steam Sterilization

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 Reusable Surgical Instrument Set]

• 00688346001198: 027-003
• 00688346000566: 027-003
• 00688346002478: Reusable Surgical Instrument Set