Catalog Number

-

Brand Name

PULSE

Version/Model Number

50130001

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

K162313

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

1b280155-871b-45d6-af8e-fc72fe7c0db5

Public Version Date

July 27, 2018

Public Version Number

1

DI Record Publish Date

June 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-