Catalog Number

89-10625

Brand Name

DeRoyal

Version/Model Number

89-10625

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

d886ce26-c5da-40df-a6ba-0385956655f2

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2021

Package DI Number

50749756364138

Quantity per Package

30

Contains DI Package

00749756364133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case