Catalog Number

-

Brand Name

PULSE

Version/Model Number

1865282

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

57d66ce7-3800-4ece-aa81-19bf5ae26bf3

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-