Catalog Number

-

Brand Name

Sunmark

Version/Model Number

000722-503-000U

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)

-

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

63cb72f5-6841-4c43-a89b-bca2e8b0965b

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

January 10, 2017

Package DI Number

60038703929535

Quantity per Package

6

Contains DI Package

00038703929533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-