Catalog Number

-

Brand Name

SoftHeat

Version/Model Number

HP215V1

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

b0f8dcf8-c1ca-48ba-91ca-486e74d1f12f

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

20328785000041

Quantity per Package

24

Contains DI Package

00328785000047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case