GUDIDData
gudid Primary ID: C7957

Coltolux (UDI C7957)

Manufactured by COLTENE/WHALEDENT INC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Coltolux - Primary ID C7957

Device Regulatory Overview

The Coltolux (Model/Catalog Number: C7957) is a medical device manufactured by COLTENE/WHALEDENT INC. This product is indexed under FDA Product Code / Category Classification EBZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
C7957
Product Code / EMDN
EBZ
Device Name
Barrier Sleeves
Database Sync Date
2026-08-09 09:03:07

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 Coltolux?

The registered manufacturer of record for Coltolux is COLTENE/WHALEDENT INC.

What is the Primary UDI-DI identifier for Coltolux?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is C7957.

What classification code is assigned to this device?

This device is registered under product classification code EBZ.

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