Catalog Number

-

Brand Name

sam coupling patch

Version/Model Number

UB-12

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"

Yes

For Single-Use

Yes

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

K130978,K130978,K130978

Product Code

PFW

Product Code Name

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Public Device Record Key

fdf09afa-0104-4434-9197-de0418bc2cf1

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

00857599005080

Quantity per Package

4

Contains DI Package

00857599005097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case