Catalog Number

D138501

Brand Name

VIZIGO

Version/Model Number

D138501

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

K170997

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

8074f250-f5d5-4c00-b3e8-5fcf2c454eba

Public Version Date

February 10, 2022

Public Version Number

4

DI Record Publish Date

May 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-