Catalog Number

-

Brand Name

Regard

Version/Model Number

CV00364F

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

OEQ

Product Code Name

Angiography/Angioplasty Kit

Public Device Record Key

9aa4dbd1-9b54-4cfb-bd11-cd461170725c

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Package DI Number

20194717108648

Quantity per Package

3

Contains DI Package

10194717108641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-