Aortic Repair Tool Kit

GUDID B040ART2

Aortic Repair Tool Kit containing Cusp Calipers and Annular Sizers

GENESEE BIOMEDICAL, INC.

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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