HydroSteer™ - Guidewires - ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Duns Number:040960379

Device Description: Guidewires

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More Product Details

Catalog Number

405058

Brand Name

HydroSteer™

Version/Model Number

405058

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Device Record Status

Public Device Record Key

d63f7c89-9922-493e-83c6-d3bfb1fc7aef

Public Version Date

September 21, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

15414734054963

Quantity per Package

5

Contains DI Package

05414734054966

Package Discontinue Date

June 29, 2018

Package Status

Not in Commercial Distribution

Package Type

-

"ST. JUDE MEDICAL CARDIOVASCULAR DIVISION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 185
3 A medical device with high risk that requires premarket approval 30