Catalog Number

-

Brand Name

Regard™

Version/Model Number

GY0579

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 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

OHD

Product Code Name

Gynecological Laparoscopic Kit

Public Device Record Key

0fdf1c12-06aa-4474-9001-e2eddb834cec

Public Version Date

September 25, 2019

Public Version Number

3

DI Record Publish Date

December 07, 2016

Package DI Number

20326053107546

Quantity per Package

2

Contains DI Package

10326053107549

Package Discontinue Date

September 24, 2019

Package Status

Not in Commercial Distribution

Package Type

-