Pathway Pain & Sensory Evaluation System MO 00007-12

GUDID 07290103039806

The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the fun

MEDOC LTD.

Thermotester, diagnostic
Primary Device ID07290103039806
NIH Device Record Key388e1e56-7f28-4ec9-8f13-3e4e20295ad2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathway Pain & Sensory Evaluation System
Version Model NumberPathway
Catalog NumberMO 00007-12
Company DUNS600469191
Company NameMEDOC LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290103039301 [Primary]
GS107290103039806 [Package]
Contains: 07290103039301
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTUEvoked Potential Stimulator, Thermal

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 Date2016-09-24

Devices Manufactured by MEDOC LTD.

07290103039011 - Medoc Main Station Software2023-06-28 Medoc Main Station Base Software
07290103039066 - CoVas2023-06-28 CoVAS USB Assy (for TSA-II, Q-Sense and AlgoMed)
07290103039073 - One Button Response Unit2023-06-28
07290103039219 - Thermode CHEPS2023-06-28 TSA 2 CHEPS Thermode Standard
07290103039233 - Q-Sense Response Unit2023-06-28 Q-Sense PRU (TSA)
07290103039240 - Q-Sense Base Assembly2023-06-28 Q-Sense Base Assembly
07290103039264 - Patient Response Unit2023-06-28 Patient Unit
07290103039653 - VSA 2 Hand Held2023-06-28 VSA 2 Hand Held

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