Catalog Number

ZZAI35

Brand Name

BodyMed

Version/Model Number

ZZAI35

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"

Yes

For Single-Use

Yes

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

K080580

Product Code

EGJ

Product Code Name

Device, Iontophoresis, Other Uses

Public Device Record Key

fcd9f79a-2d42-4d14-a887-feab1c55afbd

Public Version Date

February 27, 2020

Public Version Number

2

DI Record Publish Date

December 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-