Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00817F

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

b247777c-9526-40df-96c9-280864f64e62

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 24, 2019

Package DI Number

20194717105074

Quantity per Package

15

Contains DI Package

10194717105077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-