Catalog Number

MSWSTFA35220

Brand Name

SplashWire™

Version/Model Number

00884450529409

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

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

76a1923b-3c7e-405c-8843-8f865379b443

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

May 28, 2021

Package DI Number

10884450529406

Quantity per Package

5

Contains DI Package

00884450529409

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-