Catalog Number

-

Brand Name

Regard™

Version/Model Number

HT1069

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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)

Yes

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

910bca1f-c801-49f5-b319-aa0350d65a63

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

January 29, 2019

Package DI Number

20326053116401

Quantity per Package

10

Contains DI Package

10326053116404

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

-