Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00174

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

65b16de1-8418-45fa-b37f-3d931840feee

Public Version Date

January 17, 2020

Public Version Number

1

DI Record Publish Date

January 09, 2020

Package DI Number

20194717102004

Quantity per Package

10

Contains DI Package

10194717102007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-