The OZAKI AVPro Sizer Set

GUDID 04570057303974

Basic Sizer set for Pediatric and Small aortic annulus

TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K.

Heart valve annulus sizer, single-use

• Primary Device ID: 04570057303974
• NIH Device Record Key: 1ee8f814-f83a-41ed-8273-a7ebf865ffc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The OZAKI AVPro Sizer Set
• Version Model Number: TC-OZA-USB1YN
• Company DUNS: 718261532
• Company Name: TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K.
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com
• Phone: 1-800-334-5464
• Email: info@fehlingsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04570057303974 [Primary]

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04570057303974]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-17

On-Brand Devices [The OZAKI AVPro Sizer Set]

• 04570057304292: Circle Sizer set for Pediatric and Small aortic annulus
• 04570057304285: Circle Sizer set for Adult and Normal aortic annulus
• 04570057303974: Basic Sizer set for Pediatric and Small aortic annulus
• 04570057303967: Basic Sizer set for Adult and Normal aortic annulus