Catalog Number

-

Brand Name

Regard™

Version/Model Number

ET00262E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 21, 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

OGR

Product Code Name

Ear, Nose, And Throat Surgical Tray

Public Device Record Key

0f1d16cf-faa1-4327-97c2-5c2644564dea

Public Version Date

August 21, 2020

Public Version Number

3

DI Record Publish Date

December 12, 2019

Package DI Number

20194717100239

Quantity per Package

3

Contains DI Package

10194717100232

Package Discontinue Date

August 21, 2020

Package Status

Not in Commercial Distribution

Package Type

-