FDA.reportPublic FDA data

iCE Surgical Light

Primary DI
00684706001563
Brand
iCE Surgical Light
Company
Amico Clinical Solutions Corp
Model
iCE30m
Catalog number
C12S34
Device description
Series 1 200 DT Single CA 1000mm LCH 3P SA, 30M light
Published
2020-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684706001563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684706001563006847060015636847060015630684706001563

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(905) 764-0800agarciadeparedes@amico.com

Regulatory Flags#

DUNS number
243821688
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00684706009842iCE Surgical LightiCE30mSL-30M-GENE-CAM-DUAL-YOK-ASY 2026-04-16
00684706009859iCE Surgical LightiCE30mSL-30M-GENE-DUAL-YOK-ASY 2026-04-16
00684706009835iCE Surgical LightiCE30mSA-RAD-SHLD-OT50001FA 2026-04-06
00684706009682iCE Surgical LightiCE30mC12DH43W1 2026-01-22
00684706009699iCE Surgical LightiCE30mC14S242026-01-22
00684706009705iCE Surgical LightiCE30mC14DH32412026-01-22
00684706009712iCE Surgical LightiCE30mC313SHDSH33231441 2026-01-22
00684706009729iCE Surgical LightiCE30mC17SH412026-01-22
00684706009736iCE Surgical LightiCE30mC13D523W 2026-01-22
00684706009743iCE Surgical LightiCE30mC39BDSH767VR22026-01-22
00684706009750iCE Surgical LightiCE30mC12D1093R 2026-01-22
00684706009767iCE Surgical LightiCE30mC38SHDHB3321312026-01-22
00684706009774iCE Surgical LightiCE30mSL-30M-DUAL-YOK-ASY2026-01-22
00684706009781iCE Surgical LightiCE30mSL-MON-YOK-SNGL-G2 2026-01-22
00684706009798iCE Surgical LightiCE30mSL-30M-GEN2-DUAL-YOK-ASY 2026-01-22
00684706009811iCE Surgical LightiCE30mSL-30M-GEN2-LCH-YOK-ASY2026-01-22
00684706009828iCE Surgical LightiCE30mSA-RAD-SHLD-OT80002FA 2026-01-22
00684706009804iCE Surgical LightiCE30mSL-30M-LCH-YOK-ASY 2025-10-09
00684706009675iCE Surgical LightiCE30mC13TH432441 2025-07-25
00684706009644iCE Surgical LightiCE30mC313SHSHCSH4341112025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09