Catalog Number

-

Brand Name

Axonics

Version/Model Number

9108-R

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

P180046,P190006

Product Code

EZW

Product Code Name

Stimulator, Electrical, Implantable, For Incontinence

Public Device Record Key

94a05e28-ff25-4924-b95c-b625a6e90c57

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

November 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-