Catalog Number

686345

Brand Name

Colado CAD Ti2

Version/Model Number

686345

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

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

68c096e9-8b8d-4ece-8f8b-1d7d14fd4830

Public Version Date

January 29, 2021

Public Version Number

3

DI Record Publish Date

October 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-