Catalog Number

-

Brand Name

Brilnurse

Version/Model Number

AS8011

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143268,K143268

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

2bf00ae4-935c-45fc-89ba-83efdd0e1038

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Package DI Number

16970890320292

Quantity per Package

36

Contains DI Package

06970890320295

Package Discontinue Date

September 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton