GUDIDData
eudamed_udi Primary ID: 00607915123505

Kii Optical Access Systems (UDI 00607915123505)

Manufactured by Applied Medical Resources Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Kii Optical Access Systems - Primary ID 00607915123505

Device Regulatory Overview

The Kii Optical Access Systems (Model/Catalog Number: CTR12) is a medical device manufactured by Applied Medical Resources Corporation. This product is indexed under FDA Product Code / Category Classification K01010103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CTR12
Product Code / EMDN
K01010103
Device Name
Kii® Optical Access System, Z-Thread
Database Sync Date
2026-08-09 16:46:29

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 Kii Optical Access Systems?

The registered manufacturer of record for Kii Optical Access Systems is Applied Medical Resources Corporation.

What is the Primary UDI-DI identifier for Kii Optical Access Systems?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00607915123505.

What classification code is assigned to this device?

This device is registered under product classification code K01010103.

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