Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS1045

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 05, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

84b56cb6-779b-4b30-bfdd-b25d8f05edfb

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

May 15, 2018

Package DI Number

20326053115497

Quantity per Package

10

Contains DI Package

10326053115490

Package Discontinue Date

September 05, 2019

Package Status

Not in Commercial Distribution

Package Type

-