Catalog Number

-

Brand Name

Regard™

Version/Model Number

NU0981

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 25, 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

OJG

Product Code Name

Neurological Tray

Public Device Record Key

5dc12b6a-93a0-495f-b9ed-4ca7cfe7583e

Public Version Date

August 26, 2020

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

20326053113448

Quantity per Package

1

Contains DI Package

10326053113441

Package Discontinue Date

August 25, 2020

Package Status

Not in Commercial Distribution

Package Type

-