Duns Number:362997926
Device Description: 3 pack of Single Jar pads, 008538180071563 packs of 10ea static electrodes (PB-212), 00853 3 pack of Single Jar pads, 008538180071563 packs of 10ea static electrodes (PB-212), 008538180072311 Medical Tweezer, 00853818007170
Catalog Number
-
Brand Name
QuickScan Pads & Electrodes Pack
Version/Model Number
PB-35
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
126f20b8-699a-45ec-b9be-fe9b221027d1
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
December 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 43 |