Medium Dilator Tube

FDA UDI

Class II (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Medium Dilator Tube FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: Disposable Medium Dilator Tube 9mm FDA UDI
Model / Reference: 7332-75D FDA UDI
Description: Disposable Medium Dilator Tube 9mm FDA UDI

Identifiers

Primary DI / UDI-DI: 10840199500038 FDA UDI
510(k) Number: K120590 FDA UDI
FDA Product Code: GXZ FDA UDI
GMDN Term: Nerve-locating system probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nerve-locating system probe, single-use

Medium Dilator Tube by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K120590 also covers:

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 484e67bd-6478-4e10-8f2a-03ee933c66b1 37 fields · synced Jun 8, 2026