Catalog Number

-

Brand Name

Regard

Version/Model Number

OR00769J

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

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)

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

OJH

Product Code Name

Orthopedic Tray

Public Device Record Key

5fbfc2a3-b09d-4cb0-b577-a5ed65eaff34

Public Version Date

January 26, 2021

Public Version Number

3

DI Record Publish Date

December 10, 2020

Package DI Number

20194717108914

Quantity per Package

3

Contains DI Package

10194717108917

Package Discontinue Date

January 26, 2021

Package Status

Not in Commercial Distribution

Package Type

-