Catalog Number

-

Brand Name

APS™

Version/Model Number

8228053

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

K083124

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

6faa1a3b-56f5-424c-86f3-836dc27dc2b0

Public Version Date

August 28, 2018

Public Version Number

4

DI Record Publish Date

April 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-