DeRoyal - Prefab Fracture Bracing - DEROYAL INDUSTRIES, INC.

Duns Number:096372255

Device Description: Prefab Fracture Bracing

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More Product Details

Catalog Number

FB5000-20

Brand Name

DeRoyal

Version/Model Number

FB5000-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

IQI

Product Code Name

ORTHOSIS, LIMB BRACE

Device Record Status

Public Device Record Key

8ecd5fa4-2f40-4417-a8c6-c5e1a4a63ebc

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEROYAL INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7041
2 A medical device with a moderate to high risk that requires special controls. 4913
U Unclassified 3