Catalog Number

TW*AS418XHW

Brand Name

RUNTHROUGH

Version/Model Number

25-5211

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

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

0ed44ba8-cf37-4670-96b1-f0a04a78481d

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Package DI Number

34987350734700

Quantity per Package

5

Contains DI Package

04987350734709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box