Catalog Number

-

Brand Name

Micro14es MicroCross Catheter, CE

Version/Model Number

RCX-1014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

247c8f29-dafa-40c5-8956-ec251c1a2b0a

Public Version Date

March 31, 2020

Public Version Number

6

DI Record Publish Date

April 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-