Laser Applicator Non-cooled Instructions for Use

GUDID 17340007000529

Clinical Laserthermia Systems AB

General/multiple surgical laser system beam guide, reusable
Primary Device ID17340007000529
NIH Device Record Key8b3d075b-a6ab-41a6-bf01-6bb80830472c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Applicator Non-cooled Instructions for Use
Version Model NumberL-2016-055
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 Datetrue
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
GS117340007000529 [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 Number4
Public Version Date2018-07-06
Device Publish Date2017-07-10

On-Brand Devices [Laser Applicator Non-cooled Instructions for Use]

17340007000529L-2016-055
17340007000505L-2015-049

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