FDA.reportPublic FDA data

Thermode 30x30mm (TSA 2 AIR)

Primary DI
07290103039981
Brand
Thermode 30x30mm (TSA 2 AIR)
Company
MEDOC LTD.
Model
TSA 2 AIR 30x30
Catalog number
AS 00281
Device description
TSA 2 AIR Thermode 30x30
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LQWTest, Temperature Discrimination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQWTest, Temperature DiscriminationNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103039981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103039981072901030399817290103039981

GMDN Terms#

Term, Definition table
TermDefinition
Thermotester, diagnosticA mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600469191
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103039011Medoc Main Station SoftwareMMSSW 000122023-06-20
07290103039066CoVasCoVasAS 002132023-06-20
07290103039073One Button Response UnitOBRUDT 000122023-06-20
07290103039219 Thermode CHEPSTSA 2AS 004202023-06-20
07290103039233Q-Sense Response UnitQ-SenseAS 004032023-06-20
07290103039240Q-Sense Base AssemblyQ-SenseAS 004002023-06-20
07290103039264Patient Response UnitPRUAS 002432023-06-20
07290103039653VSA 2 Hand HeldVSA 2MO 000172023-06-20
07290103039660VSA 2 Handheld deviceVSA 2 Handheld DeviceAS 004222023-06-20
07290103039677VSA 2 Hand-Leg supportVSA 2 Leg AS 004252023-06-20
07290103039820TSA 2 Air TSA 2 Air 2023-06-20
07290103039837TSA 2 Air TSA 2 Air AS 001892023-06-20
07290103039899TSA 2TSA 2AS 001702023-06-20
07290103039905TSA 2TSA 2MO 000152023-06-20
07290103039912Thermode 30X30 (TSA 2) TSA 2 30X30AS 001762023-06-20
07290103039929Thermode 16X16 (TSA 2) Thermode 16X16AS 001772023-06-20
07290103039936Thermode fMRI 30*30mm - including fMRI filterThermode fMRIAS 001782023-06-20
07290103039943Thermode fMRI 16X16mm - including fMRI filterfMRI ThermodeAS 001792023-06-20
07290103039950Thermode CHEPS fMRI CHEPSAS 004212023-06-20
07290103039967Thermode 6mm diameterTSA 2AS 001852023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071298383STX4Hyperion Medical Technologies, Inc.LQW2026-06-02
00850071298390Monofilament SetHyperion Medical Technologies, Inc.LQW2026-06-02
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDLQW2024-01-10
07290103039011Medoc Main Station SoftwareMEDOC LTD.LQW2023-06-20
07290103039066CoVasMEDOC LTD.LQW2023-06-20
07290103039219 Thermode CHEPSMEDOC LTD.LQW2023-06-20
07290103039233Q-Sense Response UnitMEDOC LTD.LQW2023-06-20
07290103039240Q-Sense Base AssemblyMEDOC LTD.LQW2023-06-20
07290103039264Patient Response UnitMEDOC LTD.LQW2023-06-20
07290103039820TSA 2 Air MEDOC LTD.LQW2023-06-20
07290103039837TSA 2 Air MEDOC LTD.LQW2023-06-20
07290103039899TSA 2MEDOC LTD.LQW2023-06-20
07290103039905TSA 2MEDOC LTD.LQW2023-06-20
07290103039912Thermode 30X30 (TSA 2) MEDOC LTD.LQW2023-06-20
07290103039929Thermode 16X16 (TSA 2) MEDOC LTD.LQW2023-06-20
07290103039936Thermode fMRI 30*30mm - including fMRI filterMEDOC LTD.LQW2023-06-20
07290103039943Thermode fMRI 16X16mm - including fMRI filterMEDOC LTD.LQW2023-06-20
07290103039950Thermode CHEPS fMRI MEDOC LTD.LQW2023-06-20
07290103039967Thermode 6mm diameterMEDOC LTD.LQW2023-06-20
07290103039974Thermode 30x30mm (Q-Sense)MEDOC LTD.LQW2023-06-20
07290103039103Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039202Q-Sense Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039226Q-Sense Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039608Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039707Q-Sense Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039257Q-Sense CPM Thermal Sensory AnalazerMEDOC LTD.LQW2016-09-24
07290103039318Contact Heat Evoked Potential StimulatorMEDOC LTD.LQW2016-09-24