Duns Number:784316213
Device Description: 2.8oz bottle of silicone based lubricant intended for use during intercourse or masturbati 2.8oz bottle of silicone based lubricant intended for use during intercourse or masturbation.
Catalog Number
-
Brand Name
Pink
Version/Model Number
Silicone - 2.8oz
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152918,K152918
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
bd2f543d-b169-485f-82d6-d75ba8737f5f
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 2022
Package DI Number
10891306000453
Quantity per Package
12
Contains DI Package
00891306000456
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |