iCE Surgical Light C13S26

GUDID 00684706007831

Series 1, 300 DT, Single CA, 850mm, (LCH 9P SA, Single yoke, 9P Light)

Amico Clinical Solutions Corp

Operating room light
Primary Device ID00684706007831
NIH Device Record Key3f2a2c15-dcdf-4ec0-a852-f24f834c8df4
Commercial Distribution StatusIn Commercial Distribution
Brand NameiCE Surgical Light
Version Model NumberiCE30m
Catalog NumberC13S26
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
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
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100684706007831 [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 Date2024-06-03
Device Publish Date2024-05-24

On-Brand Devices [iCE Surgical Light]

00684706000825(2) iCE LED Surgical Light - Single Ceiling, i30
00684706000818(2) iCE LED Surgical Light - Single Ceiling, i25
00684706000801(2) iCE LED Surgical Light - Single Ceiling, i25
00684706000795Surgical Light - LED 160
00684706000788Surgical Light - LED 130
00684706000771iCE LED Surgical Light - Triple Ceiling, i30/Dual Monitor Holder/Rad Shield
00684706000764iCE LED Surgical Light - Triple Ceiling, i30/Single Monitor Holder/Rad Shield
00684706000757iCE LED Surgical Light - Triple Ceiling, i30/Single Monitor Holder*2
00684706000740iCE LED Surgical Light -Triple Ceiling, i30/i30/Rad Shield
00684706000733iCE LED Surgical Light - Triple Ceiling, i30/i30/Dual Monitor Holder
00684706000726iCE LED Surgical Light - Triple Ceiling, i30/i30/Single Monitor Holder
00684706000719iCE LED Surgical Light -Triple Ceiling, i30/i30/i30
00684706000702iCE LED Surgical Light - Triple Ceiling, i25/Single Monitor Holder/Rad Shield
00684706000696iCE LED Surgical Light - Triple Ceiling, i25/Single Monitor Holders
00684706000689iCE LED Surgical Light -Triple Ceiling, i25/i30/Rad Shield
00684706000672iCE LED Surgical Light -Triple Ceiling, i25/i30/Rad Shield
00684706000665iCE LED Surgical Light - Triple Ceiling, i25/i30/Dual Monitor Holder
00684706000658iCE LED Surgical Light - Triple Ceiling, i25/i30/Single Monitor Holder
00684706000641iCE LED Surgical Light - Triple Ceiling, i25/i30/Single Monitor Holder
00684706000634iCE LED Surgical Light -Triple Ceiling, i25/i30/i30
00684706000627iCE LED Surgical Light -Triple Ceiling, i25/i30/i30
00684706000610iCE LED Surgical Light -Triple Ceiling, i25/i25/Rad Shield
00684706000603iCE LED Surgical Light - Triple Ceiling, i25/i25/Dual Monitor Holder
00684706000597iCE LED Surgical Light - Triple Ceiling, i25/i25/Single Monitor Holder
00684706000580iCE LED Surgical Light - Triple Ceiling, i25/i25/Single Monitor Holder
00684706000573iCE LED Surgical Light - Triple Ceiling, i25/i25/Single Monitor Holder
00684706000566iCE LED Surgical Light -Triple Ceiling, i25/i25/i30
00684706000559iCE LED Surgical Light -Triple Ceiling, i25/i25/i30
00684706000542iCE LED Surgical Light -Triple Ceiling, i25/i25/i30
00684706000535iCE LED Surgical Light -Triple Ceiling, i25/i25/i25
00684706000528iCE LED Surgical Light -Triple Ceiling, i25/i25/i25
00684706000511iCE LED Surgical Light -Triple Ceiling, i25/i25/i25
00684706000504iCE LED Surgical Light -Triple Ceiling, i25/i25/i25
00684706000498iCE LED Surgical Light - Single Wall, i30
00684706000481iCE LED Surgical Light - Single Wall, i25
00684706000474iCE LED Surgical Light - Single Wall, i25
00684706000467iCE LED Surgical Light - Single Ceiling, i30
00684706000450iCE LED Surgical Light - Single Ceiling, i25
00684706000443iCE LED Surgical Light - Single Ceiling, i25
00684706000436iCE LED Surgical Light on Roll Stand, i30, 160,000 Lux
00684706000429iCE LED Surgical Light on Roll Stand, i25, 160,000 Lux
00684706000412iCE LED Surgical Light on Roll Stand, i25, 130,000 Lux
00684706000405iCE LED Surgical Light -Quad Ceiling, i30/i30/MH2/MH2
00684706000399iCE LED Surgical Light -Quad Ceiling, i30/i30/MH1/MH1
00684706000382iCE LED Surgical Light -Quad Ceiling, i30/i30/i30/MH1
00684706000375iCE LED Surgical Light -Quad Ceiling, i30/i30/i30/i30
00684706000368iCE LED Surgical Light -Quad Ceiling, i25/i30/MH1/MH1
00684706000351iCE LED Surgical Light -Quad Ceiling, i25/i30/MH1/MH1
00684706000344iCE LED Surgical Light -Quad Ceiling, i25/i30/i30/MH1
00684706000337iCE LED Surgical Light -Quad Ceiling, i25/i30/i30/i30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.