Catalog Number

-

Brand Name

Regard™

Version/Model Number

OR00240M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

ae1ba1c3-695f-4a5e-9519-04d0619c4d42

Public Version Date

November 25, 2019

Public Version Number

1

DI Record Publish Date

November 15, 2019

Package DI Number

20194717100048

Quantity per Package

4

Contains DI Package

10194717100041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-