canturio™te Cemented Tibia Drill Bit

GUDID 00850015699009

The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle.

Canary Medical USA LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00850015699009
• NIH Device Record Key: 4879bf79-d196-42f3-aa0d-bdc348cfa857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Cemented Tibia Drill Bit
• Version Model Number: 43-5399-058-14
• Company DUNS: 117153396
• Company Name: Canary Medical USA LLC
• 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: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015699009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200064

FDA Product Code

• QPP: Implantable Post-Surgical Kinematic Measurement Knee Device

Sterilization

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

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

[00850015699009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-30
• Device Publish Date: 2021-09-22

Devices Manufactured by Canary Medical USA LLC

• 00860003118399 - Canturio® Smart Extension 14mm (D) x 30mm (H): 2024-09-20 Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial ext
• 00850015699153 - Home Base Station (Bluetooth): 2024-09-16 The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and C
• 00850015699115 - CanarE Strap: 2023-05-25
• 00850015699122 - Canary Clinic Cart: 2023-05-25
• 00850015699139 - CanarE Charging Cradle: 2023-05-25
• 00860003118344 - CanarE – Clinic Wearable Device: 2023-05-25
• 00860003118368 - Canary Clinic Base Station: 2023-05-25
• 00860003118382 - Clinic Laptop: 2023-05-25