CORONEO Sternum retractor, small

FDA UDI

Class I (US FDA UDI)

by Coroneo Inc

Identity

Trade Name: CORONEO Sternum retractor, small FDA UDI
Generic Name: Sternum spreader FDA UDI
Device Name: The device is intended to be used for sternal retraction on adult patients. FDA UDI
Model / Reference: 1100222 FDA UDI
Description: The device is intended to be used for sternal retraction on adult patients. FDA UDI

Identifiers

Catalog Number: 1100222 FDA UDI
Primary DI / UDI-DI: 00817121000440 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Sternum spreader 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Sternum spreader

CORONEO Sternum retractor, small 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 0378c3f6-427e-4ba3-8787-91c321f05133 35 fields · synced Jun 8, 2026