CHATTANOOGA - TABLE 3D ACTIVETRAC 120V BLACK - DJO, LLC

Duns Number:081840873

Device Description: TABLE 3D ACTIVETRAC 120V BLACK

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More Product Details

Catalog Number

-

Brand Name

CHATTANOOGA

Version/Model Number

8042

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

ITH

Product Code Name

EQUIPMENT, TRACTION, POWERED

Device Record Status

Public Device Record Key

7ac20373-ff96-4066-b12d-33971dc420c3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DJO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 784
2 A medical device with a moderate to high risk that requires special controls. 1030
3 A medical device with high risk that requires premarket approval 8