Catalog Number

3100000A1

Brand Name

Apex®M

Version/Model Number

3100000A1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K150183

Product Code

KPI

Product Code Name

STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Public Device Record Key

8bdccfac-4669-4e63-b8d6-61bc14df1257

Public Version Date

March 20, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-