Catalog Number

A14040060150/A

Brand Name

Advocate™

Version/Model Number

00884450378519

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

ae64b45c-a822-4ce4-b386-09f2ce81fd36

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

January 12, 2021

Package DI Number

10884450378516

Quantity per Package

10

Contains DI Package

00884450378519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-