Catalog Number

-

Brand Name

ColdSPOT

Version/Model Number

500

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)

-

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

7b6388da-b59f-49cf-986f-0b3b8c6ba789

Public Version Date

July 30, 2019

Public Version Number

1

DI Record Publish Date

July 22, 2019

Package DI Number

20815137021071

Quantity per Package

2

Contains DI Package

00815137021077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-