Sterile Disposable Endocavity Needle Guide

FDA UDI

Class II (US FDA UDI)

by Protek Medical Products, Inc.

Identity

Trade Name: Sterile Disposable Endocavity Needle Guide FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Sterile Disposable Endocavity Needle Guide for use with Siemens EC9-4 (Acuson NX2™, NX3™, NX3™ Elite, P500™, X150™, X300™ & Sonoline G40™ Ultrasound Systems), EV9-4 (Sonoline G40™ & Acuson X150™ & X300™ Ultrasound Systems) Ultrasound Transducers FDA UDI
Model / Reference: 5480 FDA UDI
Description: Sterile Disposable Endocavity Needle Guide for use with Siemens EC9-4 (Acuson NX2™, NX3™, NX3™ Elite, P500™, X150™, X300™ & Sonoline G40™ Ultrasound Systems), EV9-4 (Sonoline G40™ & Acuson X150™ & X300™ Ultrasound Systems) Ultrasound Transducers FDA UDI

Identifiers

Catalog Number: 5480 FDA UDI
Primary DI / UDI-DI: 00841912105748 FDA UDI
510(k) Number: K971115 FDA UDI
K971722 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, single-use

Sterile Disposable Endocavity Needle Guide by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Gangi-SoftGuard Coaxial Needle — Apriomed AB · Class II

Cleared under the same submission

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: Protek Medical Products, Inc.

Sources (1)

FDA UDI 6a063fb8-d4e5-4dd5-a307-3e87cbb9a7e4 35 fields · synced Jun 6, 2026