Annular Sizer Aortic ASR-31/33

GUDID B040ASR31330

Aortic Repair Tool Kit - Annular Sizers

GENESEE BIOMEDICAL, INC.

Heart valve annulus sizer, reusable

• Primary Device ID: B040ASR31330
• NIH Device Record Key: 12430db1-2acf-4eb3-96ee-2d9f4a916ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annular Sizer Aortic
• Version Model Number: ASR-31/33
• Catalog Number: ASR-31/33
• 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	B040ASR31330 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

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

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

[B040ASR31330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [Annular Sizer Aortic]

• B040ASR31330: Aortic Repair Tool Kit - Annular Sizers
• B040ASR2729: Aortic Repair Tool Kit - Annular Sizers
• B040ASR2325: Aortic Repair Tool Kit - Annular Sizers
• B040ASR19210: Aortic Repair Tool Kit - Annular Sizers