Catalog Number

501814REC

Brand Name

ANGIOGUARD

Version/Model Number

501814REC

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

5596daa0-637e-4478-838e-985ebae4dc52

Public Version Date

February 28, 2022

Public Version Number

3

DI Record Publish Date

January 26, 2021

Package DI Number

20705032054789

Quantity per Package

1

Contains DI Package

10705032054782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX