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 Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable 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

• 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
• 00850015699016 - OR Barcode Scanner: 2021-10-07 After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other impla
• 00860003118337 - OR Laptop: 2021-10-07 Dedicated Laptop PC, part of the OR Base Station System