Catalog Number

-

Brand Name

Jiajian

Version/Model Number

pointoselect

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

K123958,K123958

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

fec9a069-2d97-4082-812f-e3a7601b5f93

Public Version Date

February 13, 2019

Public Version Number

2

DI Record Publish Date

November 12, 2018

Package DI Number

30810011251503

Quantity per Package

20

Contains DI Package

00810011251502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-