Catalog Number

-

Brand Name

Neuropen

Version/Model Number

NT0100

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GXB

Product Code Name

Esthesiometer

Public Device Record Key

740713d5-5237-42a2-be4e-7f02a5fe820c

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Package DI Number

00384700100032

Quantity per Package

100

Contains DI Package

00384700100018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case