Duns Number:081049410
Device Description: Personal Lubricant
Catalog Number
-
Brand Name
KY Liquibeads Vaginal Moisturizer
Version/Model Number
Personal Lubricant
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
K122061,K122061,K122061
Product Code
NUC
Product Code Name
Lubricant, personal
Public Device Record Key
acaccfcf-9bf9-4315-ba5c-2d9ededbc355
Public Version Date
November 12, 2019
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
20067981160462
Quantity per Package
8
Contains DI Package
10067981160465
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. | 24 |