Catalog Number

405068

Brand Name

HydroSteer™

Version/Model Number

405068

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

1ba61727-1be2-41e7-b8a0-1a7aac4cdc82

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2015

Package DI Number

15414734055069

Quantity per Package

5

Contains DI Package

05414734055062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-