Catalog Number

-

Brand Name

Regard™

Version/Model Number

OR00458F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 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

OJH

Product Code Name

Orthopedic Tray

Public Device Record Key

6aac6fae-7df8-4207-87f2-9f94a4973f9d

Public Version Date

May 07, 2020

Public Version Number

3

DI Record Publish Date

January 13, 2020

Package DI Number

20194717100574

Quantity per Package

3

Contains DI Package

10194717100577

Package Discontinue Date

May 07, 2020

Package Status

Not in Commercial Distribution

Package Type

-