Catalog Number

89-10607

Brand Name

DeRoyal

Version/Model Number

89-10607

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

OHG

Product Code Name

Circumcision tray

Public Device Record Key

178875dd-2839-4ba6-ba50-b2f5fbdfe177

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

50749756363148

Quantity per Package

60

Contains DI Package

00749756363143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case