Q-Sense Thermal Sensory Analazer MO 00013

GUDID 07290103039226

The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The Q-Sense is a pain management and pain research intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as the sensation of warmth, cold, heat-induced pain and cold-induced pain. The Device includes: main unit, one thermode/probe and accessories.

MEDOC LTD.

Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic Thermotester, diagnostic

• Primary Device ID: 07290103039226
• NIH Device Record Key: ce287f6c-0d55-4bd1-b7cf-a6c4fe929521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Sense Thermal Sensory Analazer
• Version Model Number: Q-Sense
• Catalog Number: MO 00013
• Company DUNS: 600469191
• Company Name: MEDOC LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103039202 [Primary]
GS1	07290103039226 [Package]; Contains: 07290103039202; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922052

FDA Product Code

• LQW: Test, Temperature Discrimination

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-16
• Device Publish Date: 2016-09-24

On-Brand Devices [Q-Sense Thermal Sensory Analazer]

• 07290103039707: The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including ad
• 07290103039226: The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including ad