Duns Number:057027601
Device Description: Part Number: BL-01091. Material Type: ABS, Acrylic, Silicone. Performance VX1 is a male Part Number: BL-01091. Material Type: ABS, Acrylic, Silicone. Performance VX1 is a male enhancement system that consists of a motorized pump vacuum chamber, an airtight seal and a penis ring. Batteries: AAA.
Catalog Number
BL-01091
Brand Name
Performance
Version/Model Number
VX1 Male Enhancement Pump System-Clear
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
5896efa7-4194-4ffb-b4e8-39a585484ead
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 105 |