Catalog Number

-

Brand Name

NavienTM

Version/Model Number

RFX072-130-08

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

K110055

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

1269dd56-030e-47a6-8a7b-22a1fc880bdd

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

April 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-