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Cardica Vein/Aorta Gauge

FDA UDI

Class I (US FDA UDI)

by Aesdex, Llc

Identity

Trade Name
Cardica Vein/Aorta Gauge FDA UDI
Generic Name
Open-surgery blood vessel sizer, reusable FDA UDI
Device Name
The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diameter of a target vessel for reference only. FDA UDI
Model / Reference
FG-000003 FDA UDI
Description
The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diameter of a target vessel for reference only. FDA UDI

Identifiers

Catalog Number
FG-000003 FDA UDI
Primary DI / UDI-DI
11814900000031 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Open-surgery blood vessel sizer, reusable 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery blood vessel sizer, reusable

Cardica Vein/Aorta Gauge by Aesdex, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesdex, Llc

Sources (1)

  • FDA UDI 29465ad3-be1c-42e1-8827-fb83b204d02c 34 fields · synced May 30, 2026