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

Devices Manufactured by GENESEE BIOMEDICAL, INC.

• B040ATR1 - AVATR Minimally Invasive Adult Retractor with Interchangeable Blades: 2024-09-05 Multipurpose retractor for minimally invasive use - Thorocotomy, Sternotomy,
• B040ATRAR0 - AVATR Minimally Invasive Adult Retractor with atrial and aortic rakes: 2024-09-05 Multipurpose retractor for minimally invasive use with atrial and aortic rakes - Thorocotomy, Sternotomy,
• B040CSR1 - Child Curved Sternal Retractor with Blades Only: 2024-09-05 Child Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 15 to 45kg
• B040CSRAR0 - Child Curved Sternal Retractor with Blades Only: 2024-09-05 Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg
• B040MMX1 - MINIMAX Minimally Invasive Retractor: 2024-09-05 Multipurpose retractor for minimally invasive thoracic use
• B040MMX1R0 - MINIMAX Minimally Invasive Retractor: 2024-09-05 Multipurpose retractor for minimally invasive thoracic use including radiolucent blades
• B040NSR1 - Neonatal Curved Sternal Retractor with Blades Only: 2024-09-05 Neonatal Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 0.5 to 5kg
• B040NSRAR0 - Neonatal Curved Sternal Retractor with Blades Only: 2024-09-05 Neonatal Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 0.5 to 5kg