TOF-STICKER1 TOF-STICKER1

GUDID 03665023000153

Double-sided stickers for eyebrow sensor (96 units)

IDMED

Neuromuscular transmission lead set
Primary Device ID03665023000153
NIH Device Record Keya05e7258-2f3b-4447-912b-5d0dae649783
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOF-STICKER1
Version Model NumberTOF-STICKER1
Catalog NumberTOF-STICKER1
Company DUNS260233256
Company NameIDMED
Device Count96
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103665023000153 [Primary]
GS103665023000412 [Unit of Use]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-18
Device Publish Date2018-10-04

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-STICKER12023-12-18Double-sided stickers for eyebrow sensor (96 units)
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_F2022-06-21 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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