GUDIDData
eudamed_udi Primary ID: 08682560951569

ONEGEL (UDI 08682560951569)

Manufactured by KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONEGEL - Primary ID 08682560951569

Device Regulatory Overview

The ONEGEL (Model/Catalog Number: KAFG27-11) is a medical device manufactured by KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ. This product is indexed under FDA Product Code / Category Classification V9007 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
KAFG27-11
Product Code / EMDN
V9007
Device Name
ONEGEL Lubricant Gel With Lidocaine (11 mL)
Database Sync Date
2026-08-09 17:11:01

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 ONEGEL?

The registered manufacturer of record for ONEGEL is KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ.

What is the Primary UDI-DI identifier for ONEGEL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08682560951569.

What classification code is assigned to this device?

This device is registered under product classification code V9007.

Similar Classification Devices (V9007)

Other Devices by KAF GRUP SAĞLIK HİZMETLERİ İNŞAAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ

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