Double Action Bone Rongeur

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Double Action Bone Rongeur FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: Double Action Bone Rongeur 10mm Wide Tip, 26cm Long FDA UDI
Model / Reference: 7354-06 FDA UDI
Description: Double Action Bone Rongeur 10mm Wide Tip, 26cm Long FDA UDI

Identifiers

Catalog Number: 7354-06 FDA UDI
Primary DI / UDI-DI: 10840199517807 FDA UDI
FDA Product Code: HTX FDA UDI
GMDN Term: Bone cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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 cutter

Double Action Bone Rongeur by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone cutter.

Zimmer Persona Knee System — Zimmer, Inc. · Class II
Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
Novel — ALPHATEC SPINE, INC. · Class I
Battalion — ALPHATEC SPINE, INC. · Class I
Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
Battalion — ALPHATEC SPINE, INC. · Class I
IdentiTi — ALPHATEC SPINE, INC. · Class I
Park Dental Research Corp. — Park Dental Research Corp · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Koros USA, Inc.

Sources (1)

FDA UDI 2233e986-244a-4189-814f-0ae7958fbad1 37 fields · synced May 30, 2026