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COR-VALV Atrial Retractor

FDA UDI

Class I (US FDA UDI)

by Coroneo Inc

Identity

Trade Name
COR-VALV Atrial Retractor FDA UDI
Generic Name
Surgical retractor/retraction system blade, reusable FDA UDI
Device Name
The Atrial Retractor is intended to retract atrial tissue during repair or replacement of the mitral cardiac valve. FDA UDI
Model / Reference
1010684 FDA UDI
Description
The Atrial Retractor is intended to retract atrial tissue during repair or replacement of the mitral cardiac valve. FDA UDI

Identifiers

Catalog Number
1010684 FDA UDI
Primary DI / UDI-DI
10817121000256 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Surgical retractor/retraction system blade, 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retractor/retraction system blade, reusable

COR-VALV Atrial Retractor by Coroneo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical retractor/retraction system blade, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coroneo Inc

Sources (1)

  • FDA UDI 5b8a3c73-f052-4781-b6a0-13040d0786e2 35 fields · synced Jun 1, 2026