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Aortic Repair Caliper

FDA UDI

Class I (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Aortic Repair Caliper FDA UDI
Generic Name
Aortic valve cusp height ruler FDA UDI
Device Name
Aortic Repair Tool Kit - Cusp Calipers FDA UDI
Model / Reference
ARC-8 FDA UDI
Description
Aortic Repair Tool Kit - Cusp Calipers FDA UDI

Identifiers

Primary DI / UDI-DI
B040ARC80 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: Aortic valve cusp height ruler

Aortic Repair Caliper 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 c834c9b0-c9fb-492c-b8de-4130fe333a6a 33 fields · synced Jun 8, 2026