iCE Surgical Light C13T765351

GUDID 00684706007039

S1 300DT 1600 1450 1300 3P DY SL-30M 9P DY SL-30M Sgl MH

Amico Clinical Solutions Corp

Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light
Primary Device ID00684706007039
NIH Device Record Key1c835cb8-4df8-450c-93c9-c3dcb2151e94
Commercial Distribution StatusIn Commercial Distribution
Brand NameiCE Surgical Light
Version Model NumberiCE30m
Catalog NumberC13T765351
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
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@amico.com
Phone(905) 764-0800
Emailagarciadeparedes@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

Device Identifiers

Device Issuing AgencyDevice ID
GS100684706007039 [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 Date2022-05-16
Device Publish Date2022-05-06

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00684706000498iCE LED Surgical Light - Single Wall, i30
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00684706000429iCE LED Surgical Light on Roll Stand, i25, 160,000 Lux
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00684706000399iCE LED Surgical Light -Quad Ceiling, i30/i30/MH1/MH1
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