Catalog Number

-

Brand Name

No Brand

Version/Model Number

AS100B

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

K172933,K172933

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

0027f7f0-b5b4-4a66-a47c-41b86a774158

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 23, 2019

Package DI Number

16970890321008

Quantity per Package

90

Contains DI Package

06970890321001

Package Discontinue Date

July 20, 2019

Package Status

Not in Commercial Distribution

Package Type

-