Catalog Number

ZZACOMBO

Brand Name

BodyMed

Version/Model Number

ZZACOMBO

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

K181688,K181688,K181688

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

7abf8028-c478-4d23-9bad-7f77a915836b

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

October 31, 2019

Package DI Number

20815991023013

Quantity per Package

32

Contains DI Package

10815991023016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Maston Canton