Catalog Number

9008-E

Brand Name

Axonics

Version/Model Number

9008-E

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P190006

Product Code

EZW

Product Code Name

Stimulator, Electrical, Implantable, For Incontinence

Public Device Record Key

b4dbc3b8-3902-4092-9a48-079c5493b1ea

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-