Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-8680

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OJF

Product Code Name

Hysterectomy kit

Public Device Record Key

80b168de-b490-4661-bab1-d1a9edab61d0

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756869848

Quantity per Package

3

Contains DI Package

00749756869843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case