GUDIDData
eudamed_udi Primary ID: 00607915126490

Kii Sleeves (UDI 00607915126490)

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 Sleeves - Primary ID 00607915126490

Device Regulatory Overview

The Kii Sleeves (Model/Catalog Number: CTS28) is a medical device manufactured by Applied Medical Resources Corporation. This product is indexed under FDA Product Code / Category Classification K01010101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CTS28
Product Code / EMDN
K01010101
Device Name
Kii® Sleeves, Z-Thread
Database Sync Date
2026-08-09 17:15:11

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 Kii Sleeves?

The registered manufacturer of record for Kii Sleeves is Applied Medical Resources Corporation.

What is the Primary UDI-DI identifier for Kii Sleeves?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00607915126490.

What classification code is assigned to this device?

This device is registered under product classification code K01010101.

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