GUDIDData
gudid Primary ID: 60018514

SPEC 3 (UDI 60018514)

Manufactured by COLTENE/WHALEDENT INC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SPEC 3 - Primary ID 60018514

Device Regulatory Overview

The SPEC 3 (Model/Catalog Number: 60018514) 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
60018514
Product Code / EMDN
EBZ
Device Name
SPEC 3 Tracking Tip
Database Sync Date
2026-08-09 09:03:07

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of SPEC 3?

The registered manufacturer of record for SPEC 3 is COLTENE/WHALEDENT INC.

What is the Primary UDI-DI identifier for SPEC 3?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 60018514.

What classification code is assigned to this device?

This device is registered under product classification code EBZ.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint