Catalog Number

5297478

Brand Name

LEADER

Version/Model Number

5297478

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NUH

Product Code Name

STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Public Device Record Key

8f89714c-e98b-40e6-94f0-c150e9a42b3a

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

April 14, 2017

Package DI Number

30096295130370

Quantity per Package

4

Contains DI Package

00096295130379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX