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Aortic Repair Tool Kit

FDA UDI

Class I (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Aortic Repair Tool Kit FDA UDI
Generic Name
Aortic valve cusp height ruler FDA UDI
Device Name
Aortic Repair Tool Kit containing Cusp Calipers and Annular Sizers FDA UDI
Model / Reference
ART-2 FDA UDI
Description
Aortic Repair Tool Kit containing Cusp Calipers and Annular Sizers FDA UDI

Identifiers

Primary DI / UDI-DI
B040ART2 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Aortic valve cusp height ruler FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve annulus sizer, reusableAortic valve cusp height ruler

Aortic Repair Tool Kit by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic valve cusp height ruler.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesee Biomedical, Inc.

Sources (1)

  • FDA UDI 9276cbc0-a981-4f4b-b74c-324863ba0781 33 fields · synced Jun 8, 2026