Catalog Number

-

Brand Name

Cramer Instant Cold Pack

Version/Model Number

033101

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

Yes

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

8fd5ac1e-33c8-4907-8639-e7577f795773

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 19, 2018

Package DI Number

20311960410308

Quantity per Package

4

Contains DI Package

00311960410304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton