Catalog Number

-

Brand Name

Rapport

Version/Model Number

SM 2207

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LKY

Product Code Name

Device, External Penile Rigidity

Public Device Record Key

3cef5ae4-4ee1-44a6-a7f6-b88ca11f9046

Public Version Date

March 24, 2022

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

00384702207036

Quantity per Package

1

Contains DI Package

00384702207012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case