Catalog Number

627530AN

Brand Name

Colado CC

Version/Model Number

627530AN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJH

Product Code Name

ALLOY, METAL, BASE

Public Device Record Key

3c3bc4fc-3b2d-4382-a16f-5b0d530c71eb

Public Version Date

February 26, 2020

Public Version Number

3

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-