Duns Number:260233256
Device Description: NeuroLight kit for demonstration (NeuroLight portable pupillometer NL-MU, wireless chargin NeuroLight kit for demonstration (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, user manual and robust demonstration case)
Catalog Number
NL-2-DEM
Brand Name
NL-2-DEM
Version/Model Number
NL-2-DEM
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HLG
Product Code Name
Pupillometer, Ac-Powered
Public Device Record Key
bd39ea2e-bf72-432a-b48e-e60e2247ffe2
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 2022
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |