canturio™ te Modular Bracket, Impaction Sleeve

GUDID 00850015699108

CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.

Canary Medical USA LLC

Sterilization/disinfection container, reusable

• Primary Device ID: 00850015699108
• NIH Device Record Key: f90716c3-844b-4e1f-991c-8762ef002690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™ te Modular Bracket, Impaction Sleeve
• Version Model Number: 110044505
• 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	00850015699108 [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

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

Moist Heat or Steam Sterilization

[00850015699108]

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

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• 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