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Zutron

FDA UDI

Class I (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
ZUTRON FDA UDI
Generic Name
Invasive medical device leak tester, mechanical FDA UDI
Device Name
PENTAX LEAK TESTER HANDHLD FDA UDI
Model / Reference
ZUTR10002P FDA UDI
Description
PENTAX LEAK TESTER HANDHLD FDA UDI

Identifiers

Primary DI / UDI-DI
04961333244478 FDA UDI
510(k) Number
K093718 FDA UDI
FDA Product Code
FCY FDA UDI
GMDN Term
Invasive medical device leak tester, mechanical 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Invasive medical device leak tester, mechanical

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

Similar devices

Also classified as Invasive medical device leak tester, mechanical.

Cleared under the same submission

K093718 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI 39c2c4ad-02e7-4623-ab9d-e3169cb22a8e 34 fields · synced Jun 8, 2026