gudid
Primary ID: FG-1056
C2 CryoBalloon (UDI FG-1056)
Manufactured by PENTAX OF AMERICA, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for C2 CryoBalloon - Primary ID FG-1056
Device Regulatory Overview
The C2 CryoBalloon (Model/Catalog Number: FG-1056) is a medical device manufactured by PENTAX OF AMERICA, INC.. This product is indexed under FDA Product Code / Category Classification GEH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FG-1056
- Product Code / EMDN
- GEH
- Device Name
- Database Sync Date
- 2026-08-09 09:46:00
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 C2 CryoBalloon?
The registered manufacturer of record for C2 CryoBalloon is PENTAX OF AMERICA, INC..
What is the Primary UDI-DI identifier for C2 CryoBalloon?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FG-1056.
What classification code is assigned to this device?
This device is registered under product classification code GEH.
Similar Classification Devices (GEH)
Other Devices by PENTAX OF AMERICA, INC.
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