GUDIDData
eudamed_udi Primary ID: M614TB8L8S1

DTC® (UDI M614TB8L8S1)

Manufactured by EUROSPINE SARL

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DTC® - Primary ID M614TB8L8S1

Device Regulatory Overview

The DTC® (Model/Catalog Number: TB8L8S) is a medical device manufactured by EUROSPINE SARL. This product is indexed under FDA Product Code / Category Classification P09070101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
TB8L8S
Product Code / EMDN
P09070101
Device Name
DTC Transforaminal Lumbar intervertebral fusion cage, sterile
Database Sync Date
2026-08-09 16:28:59

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 DTC®?

The registered manufacturer of record for DTC® is EUROSPINE SARL.

What is the Primary UDI-DI identifier for DTC®?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M614TB8L8S1.

What classification code is assigned to this device?

This device is registered under product classification code P09070101.

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