Catalog Number

-

Brand Name

PR-84216

Version/Model Number

PR-84216

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

-

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Public Device Record Key

e40548c6-991b-4918-b3ec-da989ded5df0

Public Version Date

November 02, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2019

Package DI Number

20850005864244

Quantity per Package

4

Contains DI Package

10850005864247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-