Duns Number:791140622
Device Description: Gold cup electrodes 60" length, (5 electrodes/pack)
Catalog Number
PV1010-13CI
Brand Name
Neurovirtual
Version/Model Number
Maxxi Gold Electrode 60"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163547
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
dc7f5682-1ef4-4f90-bc3b-7ce6642b6986
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 38 |