Catalog Number

2120-025

Brand Name

NeuroPEN

Version/Model Number

2120-025

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

K942249

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

24e7ec43-88f0-4f55-a4a7-5b070307f736

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-