NL-2 - NeuroLight kit (NeuroLight portable pupillometer - IDMED

Duns Number:260233256

Device Description: NeuroLight kit (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, NeuroLight kit (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, and user manual)

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More Product Details

Catalog Number

NL-2

Brand Name

NL-2

Version/Model Number

NL-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HLG

Product Code Name

Pupillometer, Ac-Powered

Device Record Status

Public Device Record Key

39e86502-22b6-4185-95c0-405fc09af21a

Public Version Date

June 13, 2022

Public Version Number

2

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IDMED" Characteristics
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