Catalog Number

-

Brand Name

Reusable Facial Patch

Version/Model Number

PRP-40

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PFW

Product Code Name

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Public Device Record Key

b3a3c633-703f-4430-a4de-253a6d901bc2

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-