Catalog Number

A14025300150/A

Brand Name

Advocate™

Version/Model Number

00884450377703

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

b3cec534-d35f-4509-91f5-6afb63a2a502

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

November 11, 2020

Package DI Number

10884450377700

Quantity per Package

10

Contains DI Package

00884450377703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-