Catalog Number

352506070E

Brand Name

Option Elite Retrievable Vena Cava Filter

Version/Model Number

352506070E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 2022

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

DTK

Product Code Name

Filter, Intravascular, Cardiovascular

Public Device Record Key

8efc67f8-79aa-4b10-89b4-3d5487396484

Public Version Date

June 28, 2022

Public Version Number

2

DI Record Publish Date

July 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-