Aortic Repair Tool Kit

GUDID B040ART2

Aortic Repair Tool Kit containing Cusp Calipers and Annular Sizers

GENESEE BIOMEDICAL, INC.

Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler Aortic valve cusp height ruler

• Primary Device ID: B040ART2
• NIH Device Record Key: 9276cbc0-a981-4f4b-b74c-324863ba0781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aortic Repair Tool Kit
• Version Model Number: ART-2
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040ART2 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

[B040ART2]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

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