Catalog Number

89-10231

Brand Name

DeRoyal

Version/Model Number

89-10231

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"

Yes

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

6702e246-c2cd-4c79-80b9-b19de195aa6e

Public Version Date

June 23, 2020

Public Version Number

1

DI Record Publish Date

June 15, 2020

Package DI Number

50749756351381

Quantity per Package

6

Contains DI Package

00749756351386

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case