Catalog Number

-

Brand Name

Inno Hydrowire

Version/Model Number

SW-35-260-A-3-H

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

K172187,K172187

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

08941122-2059-4e05-829e-3e2b33261c16

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 22, 2019

Package DI Number

16971564430156

Quantity per Package

5

Contains DI Package

06971564430159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-