GUDIDData
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gudid Primary ID: UTRT-4100

Opti-Tatt Dots (UDI UTRT-4100)

Manufactured by Bionix, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Opti-Tatt Dots - Primary ID UTRT-4100

Device Regulatory Overview

The Opti-Tatt Dots (Model/Catalog Number: UTRT-4100) 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-4100
Product Code / EMDN
FZZ
Device Name
Opti-Tatt, Dot, Sheet of 24
Database Sync Date
2026-08-09 09:04:11

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Opti-Tatt Dots?

The registered manufacturer of record for Opti-Tatt Dots is Bionix, LLC.

What is the Primary UDI-DI identifier for Opti-Tatt Dots?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is UTRT-4100.

What classification code is assigned to this device?

This device is registered under product classification code FZZ.

Similar Classification Devices (FZZ)

Other Devices by Bionix, LLC

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