Catalog Number

-

Brand Name

INF 4160C

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K092780,K092780

Product Code

LIH

Product Code Name

Interferential Current Therapy

Public Device Record Key

565f0f7e-b07f-4d1a-a8d0-ed7f3816085a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

14897079950014

Quantity per Package

24

Contains DI Package

04897079950017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box