Catalog Number

-

Brand Name

Regard™

Version/Model Number

HT1091

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

OES

Product Code Name

Cardiac Catheterization Kit

Public Device Record Key

6eac34b6-6537-42de-bef3-71d7db6551d5

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

20326053117255

Quantity per Package

3

Contains DI Package

10326053117258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-