Catalog Number

-

Brand Name

Confida™

Version/Model Number

GWBC30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150465,K150465

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

52fbd246-3c61-4baf-8671-ffcf5307412f

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

September 04, 2016

Package DI Number

20643169583737

Quantity per Package

5

Contains DI Package

00643169583733

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK