Catalog Number

ZZHPS1623

Brand Name

BodyMed

Version/Model Number

ZZHPS1623

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

15bd7540-1fc4-4374-88b5-103f8128ea6c

Public Version Date

February 27, 2020

Public Version Number

2

DI Record Publish Date

October 18, 2019

Package DI Number

20815991022627

Quantity per Package

6

Contains DI Package

00815991022623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton