Catalog Number

357261

Brand Name

Cruiser-18

Version/Model Number

Medium 300cm

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

-

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

1c3b7e80-a22f-464d-8dee-2d7d57da9e89

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

July 26, 2016

Package DI Number

07640119558134

Quantity per Package

5

Contains DI Package

07640130442726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case