Catalog Number

-

Brand Name

Axonpen

Version/Model Number

AH-50-110

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

K201308,K201308

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

9bf4bc14-4894-4553-8188-8536e2d6016a

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

February 08, 2022

Package DI Number

10860000321300

Quantity per Package

4

Contains DI Package

00860000321303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton