FDA.reportPublic FDA data

iCE boom and Pendant

Primary DI
00684706001648
Brand
iCE boom and Pendant
Company
Amico Clinical Solutions Corp
Model
iCE - Saturn
Catalog number
LP-H-NNNN
Device description
Saturn Series - Single Mount (Fixed Option)
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00684706001648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00684706001648006847060016486847060016480684706001648

GMDN Terms#

Term, Definition table
TermDefinition
General utility supply system, ceiling-mountedAn assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.

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

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