Catalog Number

-

Brand Name

TMW

Version/Model Number

SP-4091-104

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173052

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

f82b393d-1eb7-4f89-9dbf-16bf653ab4ae

Public Version Date

June 18, 2020

Public Version Number

2

DI Record Publish Date

August 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-