canturio™te Impaction Sleeve

GUDID 00850015699061

The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.

Canary Medical USA LLC

Orthopaedic implant impactor

• Primary Device ID: 00850015699061
• NIH Device Record Key: 70e1c526-00b6-48ae-95d1-cc922c8c98f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Impaction Sleeve
• Version Model Number: 43-5399-001-14
• 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	00850015699061 [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

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

Moist Heat or Steam Sterilization

[00850015699061]

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

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• 00860003118382 - Clinic Laptop: 2023-05-25