MIRA Minor Surgery Light L-MLED50-FS-XX-ST

GUDID 00667774000065

Mira LED 50, Floorstand, Standard Arm

Amico Lights Corporation

Fixed examination/treatment light Fixed examination/treatment light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light
Primary Device ID00667774000065
NIH Device Record Key5a96f5d4-72c5-4fe8-8a93-c5ade603b2cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIRA Minor Surgery Light
Version Model NumberMIRA
Catalog NumberL-MLED50-FS-XX-ST
Company DUNS203021407
Company NameAmico Lights Corporation
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
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@amico.com
Phone(905) 764-0800
Emailekotyk@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

Device Identifiers

Device Issuing AgencyDevice ID
GS100667774000065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSYLight, Surgical, Ceiling Mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-09

On-Brand Devices [MIRA Minor Surgery Light]

00667774000249Mira LED 90, Wall Mount, Standard Arm
00667774000232Mira LED 90, Wall Mount, Extended Arm
00667774000225Mira LED 90, Floorstand, Standard Arm
00667774000218Mira LED 90, Floorstand, Extended Arm
00667774000201Mira LED 90, Ceiling Mount, Single, Standard Arm
00667774000195Mira LED 90, Ceiling Mount, Single, Extended Arm
00667774000188Mira LED 90, Ceiling Mount, Double, Standard Arm
00667774000171Mira LED 90, Ceiling Mount, Double, Extended Arm
00667774000164Mira LED 90, Wall Mount, Standard Arm
00667774000157Mira LED 90, Wall Mount, Extended Arm
00667774000140Mira LED 65, Floorstand, Standard Arm
00667774000133Mira LED 65, Floorstand, Extended Arm
00667774000126Mira LED 65, Ceiling Mount, Single, Standard Arm
00667774000119Mira LED 65, Ceiling Mount, Single, Extended Arm
00667774000102Mira LED 65, Ceiling Mount, Double, Standard Arm
00667774000096Mira LED 65, Ceiling Mount, Double, Extended Arm
00667774000089Mira LED 50, Wall Mount, Standard Arm
00667774000072Mira LED 50, Wall Mount, Extended Arm
00667774000065Mira LED 50, Floorstand, Standard Arm
00667774000058Mira LED 50, Floorstand, Extended Arm
00667774000041Mira LED 50, Ceiling Mount, Single, Standard Arm
00667774000034Mira LED 50, Ceiling Mount, Single, Extended Arm
00667774000027Mira LED 50, Ceiling Mount, Double, Standard Arm
00667774000010Mira LED 50, Ceiling Mount, Double, Extended Arm
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