Duns Number:538025107
Device Description: VectorView HPI coil set Individual OR Package of 1 HPI coil set in a box
Catalog Number
NM20555N
Brand Name
HPI coil set (VectorView)
Version/Model Number
NM20555X
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
944728d6-924a-461c-b585-c618bbb51bff
Public Version Date
May 13, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
06430056480350
Quantity per Package
2
Contains DI Package
06430056480343
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |