Catalog Number

601814RMC

Brand Name

ANGIOGUARD

Version/Model Number

601814RMC

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

3de12b9f-5075-4ac4-b013-02d694bb149a

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

April 11, 2022

Package DI Number

20705032056745

Quantity per Package

1

Contains DI Package

10705032056748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX