gudid Primary ID: Surgical Headband 2.0 LED

SurgiTel (UDI Surgical Headband 2.0 LED)

Manufactured by Surgitel

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The SurgiTel (Model/Catalog Number: Surgical Headband 2.0 LED) is a medical device manufactured by Surgitel. This product is indexed under FDA Product Code / Category Classification KYT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Surgical Headband 2.0 LED
Product Code / EMDN: KYT
Device Name: Suplimentary light source for surgical and dental procedures.
Database Sync Date: 2026-08-09 09:12:28

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 SurgiTel?

The registered manufacturer of record for SurgiTel is Surgitel.

What is the Primary UDI-DI identifier for SurgiTel?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Surgical Headband 2.0 LED.

What classification code is assigned to this device?

This device is registered under product classification code KYT.

Similar Classification Devices (KYT)

Other Devices by Surgitel

Programmatic Export

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

JSON API Endpoint