Ultrasound Accessories - 5 cm Applicator (1/3 MHz) - Compass Richmar, LLC

Duns Number:080930531

Device Description: 5 cm Applicator (1/3 MHz)

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More Product Details

Catalog Number

-

Brand Name

Ultrasound Accessories

Version/Model Number

410-160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

IMI

Product Code Name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Device Record Status

Public Device Record Key

b736cbb4-f983-4cdb-a66e-9d7ab93f3a85

Public Version Date

December 31, 2018

Public Version Number

4

DI Record Publish Date

November 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPASS RICHMAR, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 47
2 A medical device with a moderate to high risk that requires special controls. 449