Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS0008

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

2f0992d7-4306-493d-a17e-7b88c97ef2f5

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

December 20, 2016

Package DI Number

20326053100080

Quantity per Package

16

Contains DI Package

10326053100083

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

-