Zutron

FDA UDI

Class I (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: ZUTRON FDA UDI
Generic Name: Electrical mains power extension cable FDA UDI
Device Name: ZUTRON AUTO LEAK TESTER POWER SUPPLY FDA UDI
Model / Reference: ZUTRT1079P5PND FDA UDI
Description: ZUTRON AUTO LEAK TESTER POWER SUPPLY FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333244515 FDA UDI
510(k) Number: K093718 FDA UDI
FDA Product Code: FCY FDA UDI
GMDN Term: Electrical mains power extension cable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrical mains power extension cable

Zutron by PENTAX of America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K093718 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 I	Pending data

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Manufacturer

Manufacturer: PENTAX of America, Inc.

Sources (1)

FDA UDI 7764ccc3-dd5d-4cb4-95d8-9706f03fb5a6 34 fields · synced May 31, 2026