DeRoyal - Tracker EX Concise Walker - DEROYAL INDUSTRIES, INC.

Duns Number:096372255

Device Description: Tracker EX Concise Walker

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More Product Details

Catalog Number

15580006

Brand Name

DeRoyal

Version/Model Number

15580006

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

36e4a180-bc62-4aef-82dc-c200f43abc51

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 21, 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