Catalog Number

-

Brand Name

Regard™

Version/Model Number

GU01035B

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

FDE

Product Code Name

Laparoscopy Kit

Public Device Record Key

9a8bb0ea-c127-48ee-9678-4dd34e1c3497

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

20194717105692

Quantity per Package

6

Contains DI Package

10194717105695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-