Catalog Number

-

Brand Name

Hydrophilic Guidewire

Version/Model Number

666411-011

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

K000011

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

e24a3e5d-cdac-4f74-9223-11cc6dee9f24

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

October 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-