canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.

GUDID 00850015699078

Tibial Cutting guide is placed within a tray, 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: 00850015699078
• NIH Device Record Key: 3bcceb02-ccb2-412d-afa6-56f1d79f8cc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.
• Version Model Number: 43-5907-080-27
• 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	00850015699078 [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

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

Moist Heat or Steam Sterilization

[00850015699078]

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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