Catalog Number

-

Brand Name

Regard™

Version/Model Number

NU0963

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 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

OJH

Product Code Name

Orthopedic Tray

Public Device Record Key

26f2e27a-80dd-4cb5-8d55-ae8c4b75bd76

Public Version Date

August 08, 2019

Public Version Number

3

DI Record Publish Date

November 02, 2017

Package DI Number

20326053114100

Quantity per Package

2

Contains DI Package

10326053114103

Package Discontinue Date

August 07, 2019

Package Status

Not in Commercial Distribution

Package Type

-