Curette

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Curette FDA UDI
Generic Name: General-purpose curette FDA UDI
Device Name: Spinal Adjustable Length Curette Forward-Angled 4.8mm, 26-42cm Length FDA UDI
Model / Reference: 7398-43 FDA UDI
Description: Spinal Adjustable Length Curette Forward-Angled 4.8mm, 26-42cm Length FDA UDI

Identifiers

Catalog Number: 7398-43 FDA UDI
Primary DI / UDI-DI: 10840199523334 FDA UDI
FDA Product Code: FZS FDA UDI
GMDN Term: General-purpose curette 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: Bone curette, reusable General-purpose curette Ophthalmic curette, reusable

Curette by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic curette, reusable.

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Curette — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Ambler Surgical — Ambler Surgical, LLC · 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 ffb29312-2706-42e2-ba2d-70763a42688b 37 fields · synced Jun 8, 2026