Catalog Number

C610134

Brand Name

Angio-Seal™

Version/Model Number

Evolution™

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2017

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

c1a849a9-bfe0-4cb8-9395-8f14f5625d05

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2014

Package DI Number

25415067002833

Quantity per Package

5

Contains DI Package

05415067002839

Package Discontinue Date

April 20, 2017

Package Status

Not in Commercial Distribution

Package Type

-