Catalog Number

EX500

Brand Name

Cordis ExoSeal Vascular Closure Device

Version/Model Number

EX500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

MGB

Product Code Name

DEVICE, HEMOSTASIS, VASCULAR

Public Device Record Key

4eb4f0d7-524d-4929-8c84-93d567fdc279

Public Version Date

August 03, 2022

Public Version Number

10

DI Record Publish Date

September 19, 2014

Package DI Number

20705032058879

Quantity per Package

10

Contains DI Package

10705032058872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX