Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS01032B

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

4029b1e0-f158-4f3e-8f7b-c4cef56d877e

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

November 20, 2019

Package DI Number

20194717105661

Quantity per Package

2

Contains DI Package

10194717105664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-