Catalog Number

BL-010523

Brand Name

PERFORMANCE

Version/Model Number

Universal Pump Sleeve - Anal - Vanilla

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

LKY

Product Code Name

Device, External Penile Rigidity

Public Device Record Key

926b156e-cb45-42ae-a523-b66496e2fa0d

Public Version Date

November 06, 2019

Public Version Number

1

DI Record Publish Date

October 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-