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iCE Surgical Light

FDA UDI

Class II (US FDA UDI)

by Amico Clinical Solutions Corp

Identity

Trade Name
iCE Surgical Light FDA UDI
Generic Name
Operating room light FDA UDI
Device Name
S1 200DT Dual 1150 1000 LCH 9P SL-30M Sgl MH for Barco monitor FDA UDI
Model / Reference
iCE30m FDA UDI
Description
S1 200DT Dual 1150 1000 LCH 9P SL-30M Sgl MH for Barco monitor FDA UDI

Identifiers

Catalog Number
C12D436K FDA UDI
Primary DI / UDI-DI
00684706003345 FDA UDI
FDA Product Code
FSY FDA UDI
GMDN Term
Operating room light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room light

This iCE Surgical Light is a high-intensity, multi-LED light source designed for precise illumination of surgical sites in operating rooms. Its unique design minimizes shadows and heat emission, making it ideal for complex procedures.

Similar devices

Also classified as Operating room light.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amico Clinical Solutions Corp

Sources (1)

  • FDA UDI e0c19161-948e-46a5-ab97-159a756133b3 36 fields · synced Jun 25, 2026