gudid
Primary ID: UTRT-3102
IsoMark (UDI UTRT-3102)
Manufactured by Bionix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IsoMark - Primary ID UTRT-3102
Device Regulatory Overview
The IsoMark (Model/Catalog Number: UTRT-3102) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification FZZ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- UTRT-3102
- Product Code / EMDN
- FZZ
- Device Name
- IsoMark Pink Ink
- Database Sync Date
- 2026-08-09 09:04:11
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 IsoMark?
The registered manufacturer of record for IsoMark is Bionix, LLC.
What is the Primary UDI-DI identifier for IsoMark?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is UTRT-3102.
What classification code is assigned to this device?
This device is registered under product classification code FZZ.
Similar Classification Devices (FZZ)
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