Catalog Number

-

Brand Name

Regard™

Version/Model Number

CV00247J

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

cf6a2ead-84bc-4182-ad49-03781f05f6cf

Public Version Date

December 31, 2019

Public Version Number

1

DI Record Publish Date

December 23, 2019

Package DI Number

20194717100116

Quantity per Package

1

Contains DI Package

10194717100119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-