FDA.reportPublic FDA data

Laser Applicator Non-cooled

Primary DI
17340007000840
Brand
Laser Applicator Non-cooled
Company
Clinical Laserthermia Systems AB
Model
4012-N5
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ONONeurosurgical Laser With Mr Thermography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONONeurosurgical Laser With Mr ThermographyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37340007000844PackageGS15In Commercial Distribution
17340007000840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3734000700084437340007000844
1734000700084017340007000840

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
774856749
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17340007000857Laser Applicator Non-cooled4017-N22022-10-28
17340007000864Laser Applicator Non-cooled4017-N42022-10-28
17340007000956MR Introducer4013-N62024-05-07
17340007000826Mobile Laser Unit1001-N22022-10-28
17340007000833Thermoguide Workstation1100-N12022-10-28
17340007000659Tissue Temp Probe3001-012022-10-28
17340007000666Tissue Temp Probe3001-022022-10-28
17340007000673Tissue Temp Probe3002-012022-10-28
17340007000680Tissue Temp Probe3002-022022-10-28
17340007000697Tissue Temp Probe3003-012022-10-28
17340007000703Tissue Temp Probe3003-022022-10-28
17340007000710Tissue Temp Probe3004-012022-10-28
17340007000727Tissue Temp Probe3004-022022-10-28
17340007000611Mobile Laser Unit1001-022022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USL-2019-0622022-10-28
17340007000017Mobile Laser Unit1001-012016-09-18
17340007000024Tissue Temp Probe3101-012016-09-18
17340007000031Tissue Temp Probe3101-022016-09-18
17340007000048Tissue Temp Probe3201-012016-09-18
17340007000055Tissue Temp Probe3102-012016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000521486Visualase V2 MRI-Guided Laser Ablation SystemMEDTRONIC NAVIGATION, INC.ONO2026-02-02
00763000521370VISUALASEMEDTRONIC NAVIGATION, INC.ONO2024-08-03
17340007000956MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
37340007000950MR IntroducerClinical Laserthermia Systems ABONO2024-05-07
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser ProbeMONTERIS MEDICAL INCONO2024-01-02
17340007000857Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000864Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000826Mobile Laser UnitClinical Laserthermia Systems ABONO2022-10-28
17340007000833Thermoguide WorkstationClinical Laserthermia Systems ABONO2022-10-28
37340007000844Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000851Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
37340007000868Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USClinical Laserthermia Systems ABONO2022-10-28
17340007000888Instructions for Use Laser applicator - NeuroClinical Laserthermia Systems ABONO2022-10-28
00763000521462VisualaseMEDTRONIC NAVIGATION, INC.ONO2022-04-03
00763000416423VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
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00763000218171VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-21
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00643169933361VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169933385VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169792890VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-09