GUDIDData
gudid Primary ID: TFT13C

Tenax Fiber Trans (UDI TFT13C)

Manufactured by COLTENE/WHALEDENT INC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Tenax Fiber Trans - Primary ID TFT13C

Device Regulatory Overview

The Tenax Fiber Trans (Model/Catalog Number: TFT13C) is a medical device manufactured by COLTENE/WHALEDENT INC. This product is indexed under FDA Product Code / Category Classification ELR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
TFT13C
Product Code / EMDN
ELR
Device Name
TENAX FIBER TRANS 1.3 REFILL
Database Sync Date
2026-08-09 09:03:05

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 Tenax Fiber Trans?

The registered manufacturer of record for Tenax Fiber Trans is COLTENE/WHALEDENT INC.

What is the Primary UDI-DI identifier for Tenax Fiber Trans?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TFT13C.

What classification code is assigned to this device?

This device is registered under product classification code ELR.

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