Catalog Number

-

Brand Name

HF54, Horizon

Version/Model Number

HF54, Horizon

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062256

Product Code

IMI

Product Code Name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Public Device Record Key

a0071516-13e0-43ed-a76c-b0d30f1fe340

Public Version Date

February 12, 2020

Public Version Number

1

DI Record Publish Date

February 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-