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

K181001,K181001

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

8b5b4e2a-c593-44af-b479-74c4d77031a0

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 18, 2018

Package DI Number

20763000060880

Quantity per Package

5

Contains DI Package

00763000060886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK