Catalog Number

-

Brand Name

PULSE

Version/Model Number

5050115

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

K180038

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

33b9750e-7fa6-437a-a19c-52091374db5c

Public Version Date

May 02, 2019

Public Version Number

1

DI Record Publish Date

April 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-