Catalog Number

-

Brand Name

QUELL

Version/Model Number

QE-SYZ

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

bc2cc82a-2648-497e-90ef-37f6f5514a3f

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

10851221006435

Quantity per Package

6

Contains DI Package

00851221006438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case