Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

053891156219

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

IME

Product Code Name

Pack, Hot Or Cold, Reusable

Public Device Record Key

c3a84297-2347-43d0-8331-15e82151a416

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Package DI Number

30053891156210

Quantity per Package

4

Contains DI Package

00053891156219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-