Catalog Number

SPX14135US

Brand Name

SPEX14

Version/Model Number

SPX14135US

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

K173662

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

9bf58c50-982d-48e2-9a97-747353323010

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

August 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-