Catalog Number

-

Brand Name

N/A

Version/Model Number

DI1010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093138,K093138

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

6b43ae63-2a89-4fd0-904c-18e0940d4cec

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

October 12, 2016

Package DI Number

80813520011939

Quantity per Package

32

Contains DI Package

00813520011933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA