Catalog Number

-

Brand Name

Baldoni Neuromodulation

Version/Model Number

BN19HTS

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

128535a3-e972-4623-a265-3f1b6330ac0a

Public Version Date

January 21, 2020

Public Version Number

1

DI Record Publish Date

January 13, 2020

Package DI Number

10860002528318

Quantity per Package

20

Contains DI Package

00860002528311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-