Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-9256

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

-

Prescription Use (Rx)

-

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

93adb4e0-eefe-4dbf-b994-699f3a5b3d15

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2017

Package DI Number

50749756938209

Quantity per Package

4

Contains DI Package

00749756938204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case