Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS1012

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)

-

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

OGR

Product Code Name

Ear, Nose, And Throat Surgical Tray

Public Device Record Key

5ad24349-77f4-4cfd-acbc-7c9e8014093b

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

March 30, 2018

Package DI Number

20326053115022

Quantity per Package

2

Contains DI Package

10326053115025

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

-