Catalog Number

-

Brand Name

Regard™

Version/Model Number

AN01111

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

OGD

Product Code Name

Custom Anesthesia Tray

Public Device Record Key

57bea28b-8d45-4608-bf6c-f836bf55d462

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Package DI Number

20194717109737

Quantity per Package

12

Contains DI Package

10194717109730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-