FDA.report

iCE Surgical Light

Primary DI
00684706000887
Brand
iCE Surgical Light
Company
Amico Clinical Solutions Corp
Model
iCE30
Catalog number
C16S21
Device description
Series 1, 600 DT, Single CA, 850mm, sgl monitor SA, Gen 1 monitor holder
Published
2019-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications

CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00684706000887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00684706000887006847060008876847060008870684706000887

GMDN Terms

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

TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
(905) 764-0800agarciadeparedes@amico.com

Regulatory Flags

DUNS number
243821688
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
00684706009675iCE Surgical LightiCE30mC13TH432441 2025-07-25
00684706009644iCE Surgical LightiCE30mC313SHSHCSH4341112025-07-24
00684706009651iCE Surgical LightiCE30mC33SHBSH44112025-07-24
00684706009668iCE Surgical LightiCE30mC35SHBSH44112025-07-24
00684706009330iCE Surgical LightiCE30mC15S6R 2025-07-15
00684706009347iCE Surgical LightiCE30mC15D764R 2025-07-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.FSY2026-03-24
20192253051985DevonCardinal Health 200, LLCFSY2026-03-11
00850053798016APEX LEDBurton Medical, LLCFSY2026-02-19
00684706009682iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009699iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009705iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009712iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009729iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009736iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009743iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009750iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009767iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009774iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009781iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009798iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009811iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009828iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00724995243593ALYONSTERIS CORPORATIONFSY2026-01-05
00684706009675iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-25
00684706009644iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009651iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009668iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009330iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009347iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009361iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
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00684706009392iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
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00684706009415iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15