Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS0192

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2019

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

OKE

Product Code Name

Port Introducer Kit

Public Device Record Key

b9b45260-e8d7-4c8d-99cd-a80f48105f2b

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

December 16, 2016

Package DI Number

20326053103296

Quantity per Package

8

Contains DI Package

10326053103299

Package Discontinue Date

August 07, 2019

Package Status

Not in Commercial Distribution

Package Type

-