Catalog Number

ZZA900

Brand Name

BodyMed

Version/Model Number

ZZA900

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

K122948,K122948,K122948

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

6e73bbaa-fae8-4583-9107-d1a7b4e18d3b

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 05, 2016

Package DI Number

20815802018801

Quantity per Package

20

Contains DI Package

10815802018804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton