Sterna/Form/Mitral Valve Retractor Set

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Sterna/Form/Mitral Valve Retractor Set FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Sterna/Form/Mitral Valve Retractor Set Consists of the Following: 1 x 8651-70, 1 x 8800-502, 1 x 8800-503, 2 x 8800-504, 2 x 8800-505, 1 x 8800-506, 1 x 8800-507, 1 x 8800-508, 1 x 8800-509, 1 x 8800-510, 1 x 8800-511, 1 x 8800-512 & 1 x 8800-513 FDA UDI
Model / Reference: 8800-40 FDA UDI
Description: Sterna/Form/Mitral Valve Retractor Set Consists of the Following: 1 x 8651-70, 1 x 8800-502, 1 x 8800-503, 2 x 8800-504, 2 x 8800-505, 1 x 8800-506, 1 x 8800-507, 1 x 8800-508, 1 x 8800-509, 1 x 8800-510, 1 x 8800-511, 1 x 8800-512 & 1 x 8800-513 FDA UDI

Identifiers

Catalog Number: 8800-40 FDA UDI
Primary DI / UDI-DI: 10840199544452 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Self-retaining surgical retractor, 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Self-retaining surgical retractor, reusable

Sterna/Form/Mitral Valve Retractor Set by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · 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: Koros USA, Inc.

Sources (1)

FDA UDI 4e585c88-6154-433d-a565-d3aaefc45f5e 37 fields · synced Jun 1, 2026