Catalog Number

-

Brand Name

CTC-7

Version/Model Number

CTCKFW0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

3d149f9f-4f97-4256-9b99-1da45bbda910

Public Version Date

December 07, 2021

Public Version Number

2

DI Record Publish Date

June 15, 2021

Package DI Number

18809315679401

Quantity per Package

5

Contains DI Package

08809315679404

Package Discontinue Date

December 07, 2021

Package Status

Not in Commercial Distribution

Package Type

Box