Celestial Star CS2050C-MRI-UK

GUDID 00853538008600

Sunnex

Fixed examination/treatment light
Primary Device ID00853538008600
NIH Device Record Key1a93b3c2-507b-419f-bdb2-80b41576f45f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelestial Star
Version Model NumberCS2050C-MRI-UK
Catalog NumberCS2050C-MRI-UK
Company DUNS073797367
Company NameSunnex
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com
Phone+1(800)445-7869
Emailbill.long@sunnex.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853538008600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZFDevice, medical examination, ac powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-03

On-Brand Devices [Celestial Star]

00853538008617CSLED-DLA29
00853538008600CS2050C-MRI-UK
00853538008594CSLED-C39
00853538008532CSLED-W-AU
00853538008211CSLED-D-HW
00853538008204CSLED-W-HW
00853538008198CSLED-C-HW
00853538008181CSLED-CLA29
00853538008174CSLED-D
00853538008167CSLED-C
00853538008150CSLED-W
00853538008143CSLED-M
00853538008136CS2050W-UK
00853538008129CS2050W-E
00853538008112CS2050M-UK
00853538008105CS2050M-MRI-UK
00853538008099CS2050M-MRI-E
00853538008082CS2050M-MRI
00853538008075CS2050M-E
00853538008068CS2050D-MRI
00853538008051CS2050D-29LA
00853538008044CS2050C-MRI
00853538008037CS2050D
00853538008020CS2050C
00853538008013CS2050W
00853538008006CS2050M
00853538008648CS2050C-39

Trademark Results [Celestial Star]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELESTIAL STAR
CELESTIAL STAR
79399782 not registered Live/Pending
Lufthansa Technik Aktiengesellschaft
2024-04-10
CELESTIAL STAR
CELESTIAL STAR
78293700 2958394 Dead/Cancelled
SEARS BRANDS, LLC
2003-08-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.