gudid
Primary ID: 3101
IsoMark (UDI 3101)
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 3101
Device Regulatory Overview
The IsoMark (Model/Catalog Number: 3101) 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
- 3101
- Product Code / EMDN
- FZZ
- Device Name
- IsoMark - Black Ink, 20 ct
- 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 3101.
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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