COR-VASC System with articulated arm (Small)

FDA UDI

Class I (US FDA UDI)

by Coroneo Inc

Identity

Trade Name: COR-VASC System with articulated arm (Small) FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The system consists of a small adult sternum retractor, a clamping apparatus, and a coronary artery stabilizer. FDA UDI
Model / Reference: 1100230 FDA UDI
Description: The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The system consists of a small adult sternum retractor, a clamping apparatus, and a coronary artery stabilizer. FDA UDI

Identifiers

Catalog Number: 1100230 FDA UDI
Primary DI / UDI-DI: 10817121000522 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Surgical retraction system, 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

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

Yes

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

COR-VASC System with articulated arm (Small) by Coroneo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical retraction system, reusable.

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Thompson — Thompson Surgical Instruments · Class I
Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
Thompson — Thompson Surgical Instruments · Class I
Thompson — Thompson Surgical Instruments · Class I

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 44ebe698-b994-4155-afa1-92c72bd872b4 35 fields · synced May 29, 2026