gudid Primary ID: ULT1-S

inSIGHT Ultima (UDI ULT1-S)

Manufactured by DIVERSATEK HEALTHCARE, INC.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The inSIGHT Ultima (Model/Catalog Number: ULT1-S) is a medical device manufactured by DIVERSATEK HEALTHCARE, INC.. This product is indexed under FDA Product Code / Category Classification FFX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ULT1-S
Product Code / EMDN: FFX
Device Name: inSIGHT Ultima Base System
Database Sync Date: 2026-08-09 09:16:43

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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Frequently Asked Questions

Who is the primary manufacturer of inSIGHT Ultima?

The registered manufacturer of record for inSIGHT Ultima is DIVERSATEK HEALTHCARE, INC..

What is the Primary UDI-DI identifier for inSIGHT Ultima?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ULT1-S.

What classification code is assigned to this device?

This device is registered under product classification code FFX.

Similar Classification Devices (FFX)

Other Devices by DIVERSATEK HEALTHCARE, INC.

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