Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS01031C

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

08dddb96-660a-413c-8895-f13742a9fb3d

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

20194717105654

Quantity per Package

1

Contains DI Package

10194717105657

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-