Catalog Number

15500035-NOVA

Brand Name

DeRoyal

Version/Model Number

15500035-NOVA

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

ITW

Product Code Name

JOINT, ANKLE, EXTERNAL BRACE

Public Device Record Key

b182e84c-0ab6-40c8-beb1-0f4db8310511

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-