Catalog Number

-

Brand Name

LF400

Version/Model Number

LF40100

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

K150033,K150033

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

9b9809a8-e649-42e2-9925-bdcc9b0664c6

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

18809315679982

Quantity per Package

4

Contains DI Package

08809315679985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box