Disposable Needle Guide

FDA UDI

Class II (US FDA UDI)

by Protek Medical Products, Inc.

Identity

Trade Name: Disposable Needle Guide FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Model / Reference: 5250 FDA UDI

Identifiers

Primary DI / UDI-DI: 10841912104915 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Needle guide, single-use

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

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Also classified as Needle guide, single-use.

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Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Gangi-SoftGuard Coaxial Needle — Apriomed AB · Class II

Cleared under the same submission

K971115 also covers:

K971722 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: Protek Medical Products, Inc.

Sources (1)

FDA UDI faa5a92b-03c1-4de8-8314-9ca008d6842b 33 fields · synced May 30, 2026