Duns Number:133686100
Device Description: Vacurect vacuum erection device with 10 tension systems, 4 oz personal lubricant, 4 oz fla Vacurect vacuum erection device with 10 tension systems, 4 oz personal lubricant, 4 oz flavored lubricant, 2 oz service oil, travel bag, user's guide, and lifetime warranty.
Catalog Number
-
Brand Name
Vacurect
Version/Model Number
Deluxe 1002
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
baa32541-cff9-4e06-afc5-6670f0c1fdd6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 09, 2016
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. | 2 |