Duns Number:784316213
Device Description: 0.17oz sachet of silicone based lubricant intended for use during intercourse or masturbat 0.17oz sachet of silicone based lubricant intended for use during intercourse or masturbation.
Catalog Number
-
Brand Name
Pink
Version/Model Number
Silicone - Sample
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
503d517e-501d-47f6-b6de-e7bc68a0aa83
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 2022
Package DI Number
20891306000160
Quantity per Package
50
Contains DI Package
00891306000166
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |