Bone Graft Driver, Guarded

FDA UDI

Class II (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Bone Graft Driver, Guarded FDA UDI
Generic Name: External spinal fixation system FDA UDI
Device Name: Bone Graft Driver, Guarded 10mm FDA UDI
Model / Reference: 7222-65 FDA UDI
Description: Bone Graft Driver, Guarded 10mm FDA UDI

Identifiers

Catalog Number: 7222-65 FDA UDI
Primary DI / UDI-DI: 10840199500380 FDA UDI
FDA Product Code: KWP FDA UDI
GMDN Term: External spinal fixation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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: External spinal fixation system

Bone Graft Driver, Guarded by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Koros USA, Inc.

Sources (1)

FDA UDI 27d02e3a-3fa8-4be1-a879-274e3103a952 37 fields · synced Jun 8, 2026