Catalog Number

DSPSCRBPNTGRM-RG

Brand Name

Regard™

Version/Model Number

DSPSCRBPNTGRM-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

b2527d0b-7b99-4009-8116-62471c70a001

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

20326053119068

Quantity per Package

70

Contains DI Package

10326053119061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-