Catalog Number

ZZHP147

Brand Name

BodyMed

Version/Model Number

ZZHP147

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

c13c1bf5-78fa-4f18-b012-b8ef7f3147f3

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

20815802010140

Quantity per Package

10

Contains DI Package

10815802010143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton