Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00087P

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

fff49227-f960-4551-8cbf-3bc206a990f7

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

20194717116216

Quantity per Package

4

Contains DI Package

10194717116219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-