Catalog Number

-

Brand Name

CONFIANZA

Version/Model Number

AG143390

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

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

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

a625d201-540d-4d6f-8df5-a5750f5343c0

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

14547327055762

Quantity per Package

5

Contains DI Package

04547327055765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-