FDA.reportPublic FDA data

The OZAKI AVPro Sizer Set

Primary DI
04570057303974
Brand
The OZAKI AVPro Sizer Set
Company
TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K.
Model
TC-OZA-USB1YN
Device description
Basic Sizer set for Pediatric and Small aortic annulus
Published
2026-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTISizer, Heart-Valve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04570057303974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04570057303974045700573039744570057303974

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve annulus sizer, single-useA hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-334-5464info@fehlingsurgical.com

Regulatory Flags#

DUNS number
718261532
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04570057303967The OZAKI AVPro Sizer SetTC-OZA-USB1XN2026-01-17
04570057304285The OZAKI AVPro Sizer SetTC-OZA-USC0XN2026-01-17
04570057304292The OZAKI AVPro Sizer SetTC-OZA-USC0YN2026-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067052964Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067052971Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067052988Epic™ST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054197NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054203NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054210NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054227NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054234NAST. JUDE MEDICAL, INC.DTI2026-07-08
05415067054241NAST. JUDE MEDICAL, INC.DTI2026-07-08
00763000990657Mosaic Neo™ S310MNHMEDTRONIC, INC.DTI2026-04-13
00763000990664Mosaic Neo™ S310MNSMEDTRONIC, INC.DTI2026-04-13
00690103019643HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019650HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019674HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019698HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019704HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019711HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019742HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019759HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019780HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06