CHATTANOOGA - THERATHERM MOIST HEAT 7X15 SM - DJO, LLC

Duns Number:081840873

Device Description: THERATHERM MOIST HEAT 7X15 SM

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More Product Details

Catalog Number

-

Brand Name

CHATTANOOGA

Version/Model Number

1030

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IRT

Product Code Name

PAD, HEATING, POWERED

Device Record Status

Public Device Record Key

91159a0a-e848-4b9e-b941-ef9ce1757a02

Public Version Date

May 26, 2022

Public Version Number

3

DI Record Publish Date

September 12, 2016

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