TOF-DEMO_F TOF-DEMO_F

GUDID 03665023000375

Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2_B, TOF-PS2_B, TOF-FS_B, TOF-ES_B sensors, cable support, user manual)

IDMED

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Primary Device ID03665023000375
NIH Device Record Key454811de-2106-4da6-8a6d-b616206a8cf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOF-DEMO_F
Version Model NumberTOF-DEMO_F
Catalog NumberTOF-DEMO_F
Company DUNS260233256
Company NameIDMED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103665023000375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOIStimulator, Nerve, Peripheral, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-10

Devices Manufactured by IDMED

03665023000030 - TOF-MU2023-12-18 Main unit ToFscan
03665023000122 - TOF-CHAR_US2023-12-18 AC Power / Charger (US electrical sockets)
03665023000153 - TOF-STICKER12023-12-18 Double-sided stickers for eyebrow sensor (96 units)
03665023000344 - TOF-MU2023-12-18 Main unit ToFscan
03665023000047 - TOF-S22023-03-01 Hand sensor and electrodes connector
03665023000078 - TOF-ES2023-03-01 Eyebrow sensor and electrodes connector
03665023000368 - TOF-DEMO2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp
03665023000375 - TOF-DEMO_F2022-06-21Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2_B, TOF-PS2_B, TOF-FS_B, TOF-ES_B sensors, cable support, user manual)
03665023000375 - TOF-DEMO_F2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp

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