Laser Warning Sign

GUDID 17340007000154

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
Primary Device ID17340007000154
NIH Device Record Key5c8474b8-bdc6-4c47-8a8e-7737df7715ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Warning Sign
Version Model Number4003-01
Company DUNS774856749
Company NameClinical Laserthermia Systems AB
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117340007000154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

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 Date2016-09-18

Devices Manufactured by Clinical Laserthermia Systems AB

17340007000611 - Mobile Laser Unit2022-11-07
37340007000653 - Tissue Temp Probe2022-11-07
37340007000660 - Tissue Temp Probe2022-11-07
37340007000677 - Tissue Temp Probe2022-11-07
37340007000684 - Tissue Temp Probe2022-11-07
37340007000691 - Tissue Temp Probe2022-11-07
37340007000707 - Tissue Temp Probe2022-11-07
37340007000714 - Tissue Temp Probe2022-11-07

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