SurgiTel

FDA UDI

Class I (US FDA UDI)

by Surgitel

Identity

Trade Name: SurgiTel FDA UDI
Generic Name: Operating room light FDA UDI
Device Name: Suplimentary light source for surgical and dental procedures. FDA UDI
Model / Reference: Wireless LED Headlight FDA UDI
Description: Suplimentary light source for surgical and dental procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810114912034 FDA UDI
FDA Product Code: KYT FDA UDI
GMDN Term: Operating room light FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Operating room light

SurgiTel by Surgitel — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light.

iCE Surgical Light — Amico Clinical Solutions Corp · Class II
iCE Surgical Light — Amico Clinical Solutions Corp · Class II
Medical Boom — Amico Clinical Solutions Corp · Class II
HarmonyAIR — STERIS CORPORATION · Class II
HarmonyAIR — STERIS CORPORATION · Class II
Medical Boom — Amico Clinical Solutions Corp · Class II
iCE Surgical Light — Amico Clinical Solutions Corp · Class II
HarmonyAIR — STERIS CORPORATION · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Surgitel

Sources (1)

FDA UDI db7decf3-4229-4add-9cc9-a08e4d3c95a8 33 fields · synced May 29, 2026