Catalog Number

-

Brand Name

Regard™

Version/Model Number

AN01084C

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

4db6d15f-97ae-423b-a7f7-cb6d2f3ce23d

Public Version Date

August 31, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2020

Package DI Number

20194717107672

Quantity per Package

15

Contains DI Package

10194717107675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-