Catalog Number

601814REC

Brand Name

ANGIOGUARD

Version/Model Number

601814REC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NTE

Product Code Name

Temporary Carotid Catheter for Embolic Capture

Public Device Record Key

fc0937ed-3125-472b-afa5-86c2f6807f62

Public Version Date

February 28, 2022

Public Version Number

3

DI Record Publish Date

January 26, 2021

Package DI Number

20705032056721

Quantity per Package

1

Contains DI Package

10705032056724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX