gudid
Primary ID: 28500
SutureOut (UDI 28500)
Manufactured by Bionix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SutureOut - Primary ID 28500
Device Regulatory Overview
The SutureOut (Model/Catalog Number: 28500) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification FZT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 28500
- Product Code / EMDN
- FZT
- Device Name
- SutureOut, 3ct Sample
- 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 SutureOut?
The registered manufacturer of record for SutureOut is Bionix, LLC.
What is the Primary UDI-DI identifier for SutureOut?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 28500.
What classification code is assigned to this device?
This device is registered under product classification code FZT.
Similar Classification Devices (FZT)
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