Catalog Number

-

Brand Name

Regard

Version/Model Number

GS00823E

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

fa9d64c3-34d4-4b90-9cfd-b17bdd8e2d78

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

November 29, 2021

Package DI Number

20194717114038

Quantity per Package

25

Contains DI Package

10194717114031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-