Catalog Number

-

Brand Name

FloWire Floppy Doppler Guide Wire JTIP

Version/Model Number

1400J

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"

Yes

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

K972762

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

c1b3df79-e31f-46d4-aaa9-4254ec3da923

Public Version Date

February 28, 2022

Public Version Number

5

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-