Aortic Prosthesis Indexing Cone

FDA UDI

Class I (US FDA UDI)

by Coroneo Inc

Identity

Trade Name: Aortic Prosthesis Indexing Cone FDA UDI
Generic Name: Medical ruler, reusable FDA UDI
Device Name: The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm. FDA UDI
Model / Reference: 1010605 FDA UDI
Description: The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm. FDA UDI

Identifiers

Catalog Number: 1010605 FDA UDI
Primary DI / UDI-DI: 10817121000171 FDA UDI
FDA Product Code: FTY FDA UDI
GMDN Term: Medical ruler, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medical ruler, reusable

Aortic Prosthesis Indexing Cone by Coroneo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Coroneo Inc

Sources (1)

FDA UDI a5ee3ec9-9799-4c46-a811-475a6f6812f3 35 fields · synced May 31, 2026