FDA.reportPublic FDA data

MR Introducer

Primary DI
37340007000950
Brand
MR Introducer
Company
Clinical Laserthermia Systems AB
Model
4013-N6
Published
2024-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214125000TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB2022-09-22ONO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37340007000950PackageGS15In Commercial Distribution
57340007000954PackageGS110In Commercial Distribution
17340007000956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3734000700095037340007000950
5734000700095457340007000954
1734000700095617340007000956

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
774856749
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17340007000840Laser Applicator Non-cooled4012-N52022-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000540104VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540111VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
00763000540128VisualaseMEDTRONIC NAVIGATION, INC.ONO2026-03-27
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
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser ProbeMONTERIS MEDICAL INCONO2024-01-02
17340007000840Laser Applicator Non-cooledClinical Laserthermia Systems ABONO2022-10-28
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
00763000416430VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000416447VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-10-02
00763000402082VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-05-06
00763000402099VisualaseMEDTRONIC NAVIGATION, INC.ONO2021-01-29
00763000313364VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-06-27
00763000357504VisualaseMEDTRONIC NAVIGATION, INC.ONO2020-05-17
00763000218171VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-21
00763000218188VisualaseMEDTRONIC NAVIGATION, INC.ONO2019-03-18
00643169933361VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169933385VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-11
00643169792890VisualaseMEDTRONIC NAVIGATION, INC.ONO2017-12-09