Thermode 6mm diameter AS 00185

GUDID 07290103039967

TSA 2 Intra Oral Thermode

MEDOC LTD.

Thermotester, diagnostic
Primary Device ID07290103039967
NIH Device Record Keyed0db4c9-c7b5-4e9a-8cb8-ccf2cab7c134
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermode 6mm diameter
Version Model NumberTSA 2
Catalog NumberAS 00185
Company DUNS600469191
Company NameMEDOC LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS107290103039967 [Primary]

FDA Product Code

LQWTest, Temperature Discrimination

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.