Duns Number:063041611
Device Description: Sage Personal Moisturizer and Lubricant is for penile and/or vaginal application, intended Sage Personal Moisturizer and Lubricant is for penile and/or vaginal 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
-
Brand Name
Sage Personal Moisturizer and Lubricant
Version/Model Number
1
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
K190150
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
1b3197a4-c70d-4e0c-87d7-7cf4debb59ec
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
May 07, 2020
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. | 4 |