Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS1075

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

FDE

Product Code Name

Laparoscopy Kit

Public Device Record Key

d8f010bc-8152-4948-8a70-76b6653af474

Public Version Date

August 12, 2019

Public Version Number

1

DI Record Publish Date

August 02, 2019

Package DI Number

20326053117132

Quantity per Package

2

Contains DI Package

10326053117135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-