Catalog Number

A14035080090/A

Brand Name

Advocate™

Version/Model Number

00884450378045

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

0856c766-b3d0-4752-9514-f78e225c6ed8

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

November 18, 2020

Package DI Number

10884450378042

Quantity per Package

10

Contains DI Package

00884450378045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-