gudid
Primary ID: ZUTR10003P
ZUTRON (UDI ZUTR10003P)
Manufactured by PENTAX OF AMERICA, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ZUTRON - Primary ID ZUTR10003P
Device Regulatory Overview
The ZUTRON (Model/Catalog Number: ZUTR10003P) is a medical device manufactured by PENTAX OF AMERICA, INC.. This product is indexed under FDA Product Code / Category Classification FCY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ZUTR10003P
- Product Code / EMDN
- FCY
- Device Name
- LEAK TESTER - COUNTER
- Database Sync Date
- 2026-08-09 09:46:01
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ZUTRON?
The registered manufacturer of record for ZUTRON is PENTAX OF AMERICA, INC..
What is the Primary UDI-DI identifier for ZUTRON?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ZUTR10003P.
What classification code is assigned to this device?
This device is registered under product classification code FCY.
Similar Classification Devices (FCY)
Other Devices by PENTAX OF AMERICA, INC.
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