Catalog Number

-

Brand Name

Nix

Version/Model Number

10363736000155

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LIL

Product Code Name

Monitor, Penile Tumescence

Public Device Record Key

7287ee90-8779-4e91-a27c-593acf7d2e1f

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

10363736000155

Quantity per Package

1

Contains DI Package

00363736000158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single