Catalog Number

DSPSCRBSHTGRM-RG

Brand Name

Regard™

Version/Model Number

DSPSCRBSHTGRM-RG

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

79663db3-2b3b-454d-aa22-6af05660caaa

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

20326053119020

Quantity per Package

94

Contains DI Package

10326053119023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-