Catalog Number

-

Brand Name

Regard

Version/Model Number

HT00468H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2020

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

OES

Product Code Name

Cardiac Catheterization Kit

Public Device Record Key

b34a809f-1786-4460-bcc2-144941b3b7e0

Public Version Date

December 23, 2020

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

20194717108891

Quantity per Package

3

Contains DI Package

10194717108894

Package Discontinue Date

December 23, 2020

Package Status

Not in Commercial Distribution

Package Type

-