Catalog Number

-

Brand Name

Inno-Pathwire

Version/Model Number

IW-14-190-MDS

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

K182553,K182553

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

3b5149fc-3399-437f-8d8f-e70f6404c50e

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Package DI Number

16971564430194

Quantity per Package

5

Contains DI Package

06971564430197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-