Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS1125

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

959e1e35-6590-468e-b534-463538574bf7

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

10849027005240

Quantity per Package

24

Contains DI Package

00849027005243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case