Medical Boom LP-8118-N-N

GUDID 00684706008715

800mm 1000mm Normal Arm - 1000mm 800mm Normal Arm

Amico Clinical Solutions Corp

Operating room light
Primary Device ID00684706008715
NIH Device Record Key3f7d1ae0-b3dd-43bb-8b1e-c0b229d8ad35
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical Boom
Version Model NumberLP
Catalog NumberLP-8118-N-N
Company DUNS243821688
Company NameAmico Clinical Solutions Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com
Phone(905) 764-0800
Emailccha@amico.com

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100684706008715 [Primary]

FDA Product Code

FSYLight, Surgical, Ceiling Mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-31
Device Publish Date2025-01-23

On-Brand Devices [Medical Boom]

00684706009156iCE Series - Single Mount Dual Arm 1000-800 PLP
006847060091491400mm 750mm V-Series (115U)
00684706009132iCE V Series - 1200-950 90KG 220V AUS
00684706009125iCE V Series - 1000-950 90KG 220V AUS
00684706009118iCE V Series+iCE SeriesTandem Mounted - 1000-750, 1000-1000, 90KG 115V US
006847060091011000mm 1000mm V-Series Arm (220A) - 1000mm 1000mm Normal Arm
00684706009095iCE V Series X Rampart - 1000-1000 90KG 115V US
00684706009088800mm 1000mm Normal Arm - 1000mm 800mm PLP Arm
00684706009071800mm Normal Arm
00684706009064800mm 800mm Normal Arm
00684706009057800mm 1000mm V-Series Arm (220A) - 1000mm 1000mm Normal Arm
0068470600904048" ROTATING SATURN MOUNT 12.5X14
006847060090331000mm 1000mm V-Series (220A)
00684706009026iCE Series - Single Mount Dual Arm (1000mm-800mm)
006847060090191000mm Normal Arm
00684706009002HAMMER HEAD CONSOLE BEARING 6" DROP TUBE
00684706008999Amico Hub (1400mm 1000mm Normal Boom Arm and 1150mm 1000mm CA Arm)
006847060089821200mm 1000mm V-Series Arm (115I) - 1200mm 1000mm Normal Arm
00684706008975Amico Hub (1400mm 1000mm V-Series Arm and 1150mm 1000mm CA Arm)
00684706008968800mm 1000mm V-Series - 800mm 1000mm V-Series (220A)
006847060089511000mm 750mm V-Series (115U) - 1000mm 800mm PLP
006847060089441000mm 750mm V-Series (220A)
006847060089371000mm 800mm PLP
00684706008920800mm 1000mm Normal Arm
0068470600891334" ROTATING SATURN MOUNT 12.5X9
0068470600890626" ROTATING SATURN MOUNT 12.5X9
006847060088901000mm 1000mm Normal Arm
006847060088831200mm 1000mm V-Series Arm (115I) - 800mm 800mm Normal Arm
006847060088761200mm 1000mm V-Series (115I)
006847060088691200mm 1000mm V-Series Arm (115I) - 1200mm 1000mm Normal Arm
00684706008852800mm 800mm Normal Arm - 1200mm 800mm PLP Arm
006847060088451000mm 1000mm V-Series (115U)
0068470600883837" ROTATING SATURN MOUNT 18X9
00684706008821Amico Hub (1200mm 1000mm V-Series Arm and 850 MH CA Arm)
006847060088141000mm 1000mm V-Series (115U) - 1200mm 1000mm PLP
00684706008807800mm 750mm V-Series (115U)
00684706008791800mm 750mm V-Series (220A)
006847060087841200mm 1200mm Normal Arm
006847060087771200mm 1000mm V-Series (115U)
006847060087601000mm 800mm Normal Arm
00684706008753800mm 800mm Normal Arm - 800mm 800mm Normal Arm
00684706008746800mm 800mm Normal Arm
00684706008739800mm 800mm Normal Arm - 1000mm 800mm PLP
00684706008722800mm 1000mm V-Series - 800mm 1000mm V-Series (220A)
00684706008715800mm 1000mm Normal Arm - 1000mm 800mm Normal Arm
0068470600870843" ROTATING SATURN MOUNT 18X9
006847060086921000mm 750mm V-Series (115U)
006847060086851200mm 1000mm Normal Arm
00684706008531Amico Hub (1400mm 1000mm V-Series Arm and 1150mm 1000mm CA Arm)
00684706009224Amico Hub (1200mm 1000mm V-Series Arm and 850 MH CA Arm)

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