CHATTANOOGA - THERATHERM MOIST HEAT 14X27STD - DJO, LLC

Duns Number:081840873

Device Description: THERATHERM MOIST HEAT 14X27STD

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More Product Details

Catalog Number

-

Brand Name

CHATTANOOGA

Version/Model Number

1032-B

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

Yes

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

51a8006f-a7f1-466b-af9a-94d1a3db1f12

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

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