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CardioBay Interchangeable Blade

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name
CardioBay Interchangeable Blade FDA UDI
Generic Name
Surgical retractor/retraction system blade, reusable FDA UDI
Device Name
CardioBay Interchangeable Blade Small Set of 4 FDA UDI
Model / Reference
8980-20 FDA UDI
Description
CardioBay Interchangeable Blade Small Set of 4 FDA UDI

Identifiers

Catalog Number
8980-20 FDA UDI
Primary DI / UDI-DI
10840199538772 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retractor/retraction system blade, reusable

CardioBay Interchangeable Blade by Koros USA, 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
Koros USA, Inc.

Sources (1)

  • FDA UDI fae300c8-9ffc-4adc-99e0-981d638106e2 37 fields · synced Jun 1, 2026