Catalog Number

-

Brand Name

COLD AS ICE

Version/Model Number

250

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

IFI

Product Code Name

Sprays, Synthetic, Smear

Public Device Record Key

90b8a138-bb4b-47af-86b0-a52b9ad08847

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 21, 2017

Package DI Number

00852509006058

Quantity per Package

12

Contains DI Package

00852509006027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX