Catalog Number

-

Brand Name

Regard™

Version/Model Number

361094

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

28795537-827b-43c1-932b-3b43331fcf4d

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

October 30, 2019

Package DI Number

10326053109307

Quantity per Package

20

Contains DI Package

00326053109300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-