Catalog Number

EB6000-01

Brand Name

DeRoyal

Version/Model Number

EB6000-01

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

IQI

Product Code Name

ORTHOSIS, LIMB BRACE

Public Device Record Key

ef8c998c-8904-483c-89a0-f6edd467e063

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-