Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00177P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 15, 2020

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

PXC

Product Code Name

Personal Protection Kit

Public Device Record Key

baa2d89e-fd2d-4c95-804c-922d1d3375ca

Public Version Date

September 10, 2021

Public Version Number

4

DI Record Publish Date

January 22, 2020

Package DI Number

20194717106767

Quantity per Package

4

Contains DI Package

10194717106760

Package Discontinue Date

September 15, 2020

Package Status

Not in Commercial Distribution

Package Type

-