Catalog Number

-

Brand Name

PrimeWire Prestige Plus Pressure Guide Wire 300cm JTIP

Version/Model Number

9300J

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

K111395

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

396c7ebe-742a-4408-9eaa-015382b44c86

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-