PDC Restorer

GUDID B1870790

Conductive pad, 2 in. x 3 in., 2/package

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use
Primary Device IDB1870790
NIH Device Record Keyfcd34285-e1d8-4783-8509-c93d48caad59
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDC Restorer
Version Model NumberPLB066-2030
Company DUNS147018519
Company NameNEUROTRON MEDICAL, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCB1870790 [Unit of Use]
HIBCCB1870791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-22
Device Publish Date2024-10-14

On-Brand Devices [PDC Restorer]

B1870620Electrolyte solution, 4 oz. spray bottle
B1870490Conductive duo-glove, dual polarity, 1/package
B1870480Conductive duo-sock, dual polarity, 1/package
B1870460Conductive sock (std.), single polarity, 1/package
B1870450Conductive glove, single polarity, 1/package
B1870740Conductive duo-elbow, dual polarity, 1/package
B1870760Conductive duo-sock, dual polarity, X-Large, 1/package
B1870770Conductive duo-knee, dual polarity, 1/package
B1870780Conductive pad, 3 in. x 5 in., 2/package
B1870790Conductive pad, 2 in. x 3 in., 2/package
B1870470Conductive pad, 1.5 in. x 8 in., 2/package

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