Tissue Temp Probe

GUDID 37340007000707

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system
Primary Device ID37340007000707
NIH Device Record Key8a74a6e1-2759-4e6d-9b4c-9a46ccca22fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue Temp Probe
Version Model Number3003-02
Company DUNS774856749
Company NameClinical Laserthermia Systems AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS117340007000703 [Primary]
GS137340007000707 [Package]
Contains: 17340007000703
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-28

On-Brand Devices [Tissue Temp Probe]

173400070001093203-01
173400070000933103-02
173400070000863103-01
173400070000793202-01
173400070000623102-02
173400070000553102-01
173400070000483201-01
173400070000313101-02
173400070000243101-01
373400070007213004-02
373400070007143004-01
373400070007073003-02
373400070006913003-01
373400070006843002-02
373400070006773002-01
373400070006603001-02
373400070006533001-01
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