Catalog Number

-

Brand Name

Regard™

Version/Model Number

ET0855

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 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)

-

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

dd0dc224-7c85-405c-896b-8f8064501c9c

Public Version Date

January 29, 2019

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

20326053112984

Quantity per Package

10

Contains DI Package

10326053112987

Package Discontinue Date

January 28, 2019

Package Status

Not in Commercial Distribution

Package Type

-