Catalog Number

-

Brand Name

Regard™

Version/Model Number

GY1067

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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

OHD

Product Code Name

Gynecological Laparoscopic Kit

Public Device Record Key

590aee4b-259e-4dea-8488-6daf22335d46

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

February 19, 2019

Package DI Number

20326053116449

Quantity per Package

3

Contains DI Package

10326053116442

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

-