Duns Number:153909531
Device Description: Personal lubricant for vaginal/penile application intended to moisturize and lubricate, to Personal lubricant for vaginal/penile application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
Catalog Number
200705
Brand Name
BioNude Ultra Sensitive Personal Lubricant
Version/Model Number
5 mL
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
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
K180136,K180136
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
5bc65e6e-afaf-4e31-aca3-645ecee41b2e
Public Version Date
April 20, 2022
Public Version Number
1
DI Record Publish Date
April 12, 2022
Package DI Number
30850014621217
Quantity per Package
900
Contains DI Package
00893268000260
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |