canturio™te Canary Tibial Ext 14x58mm X-Ray Template

GUDID 00850015699092

The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.

Canary Medical USA LLC

Surgical implant template, reusable

• Primary Device ID: 00850015699092
• NIH Device Record Key: 3a7914f9-7c2e-4fd1-ac05-1182ffe80b03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Canary Tibial Ext 14x58mm X-Ray Template
• Version Model Number: 43-5570-004-14
• 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	00850015699092 [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

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

Moist Heat or Steam Sterilization

[00850015699092]

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