Primary Device ID | B1870450 |
NIH Device Record Key | ab068611-b9b7-4b6b-a9c8-315d13b935fd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PDC Restorer |
Version Model Number | PLB066-3015C |
Company DUNS | 147018519 |
Company Name | NEUROTRON MEDICAL, INC. |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B1870450 [Primary] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-24 |
B1870620 | Electrolyte solution, 4 oz. spray bottle |
B1870490 | Conductive duo-glove, dual polarity, 1/package |
B1870480 | Conductive duo-sock, dual polarity, 1/package |
B1870460 | Conductive sock (std.), single polarity, 1/package |
B1870450 | Conductive glove, single polarity, 1/package |
B1870740 | Conductive duo-elbow, dual polarity, 1/package |
B1870760 | Conductive duo-sock, dual polarity, X-Large, 1/package |
B1870770 | Conductive duo-knee, dual polarity, 1/package |
B1870780 | Conductive pad, 3 in. x 5 in., 2/package |
B1870790 | Conductive pad, 2 in. x 3 in., 2/package |
B1870470 | Conductive pad, 1.5 in. x 8 in., 2/package |