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Sterile Disposable Endocavity Needle Guide Kit

FDA UDI

Class II (US FDA UDI)

by Protek Medical Products, Inc.

Identity

Trade Name
Sterile Disposable Endocavity Needle Guide Kit FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi C41V1 and EUP-73W Ultrasound Transducers FDA UDI
Model / Reference
5373 FDA UDI
Description
Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi C41V1 and EUP-73W Ultrasound Transducers FDA UDI

Identifiers

Catalog Number
5373 FDA UDI
Primary DI / UDI-DI
00841912106165 FDA UDI
FDA Product Code
ITX FDA UDI
KKX FDA UDI
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, single-useBody-orifice ultrasound imaging transducer cover, basic

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

Similar devices

Also classified as Body-orifice ultrasound imaging transducer cover, basic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Protek Medical Products, Inc.

Sources (1)

  • FDA UDI e76bf836-d834-4a87-90ed-4336f27f2497 34 fields · synced May 31, 2026