Catalog Number

537114X

Brand Name

WIZDOM

Version/Model Number

537114X

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

e2f56106-3961-4e18-b4d9-4be4df3398c4

Public Version Date

February 15, 2022

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

20705032056486

Quantity per Package

5

Contains DI Package

10705032056489

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX