Catalog Number

PAL-01

Brand Name

Penile Adjustable Loop

Version/Model Number

PAL-01

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)

-

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

a7500a4e-8fe1-4d6d-854d-348323bdf165

Public Version Date

March 08, 2019

Public Version Number

1

DI Record Publish Date

February 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-