Duns Number:008965063
Device Description: This device is a personal lubricant, for penile and/or vaginal application, intended to mo This device is a personal lubricant, 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
80029
Brand Name
Well at Walgreens
Version/Model Number
80029
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
K062682,K062682
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
1df392dd-91e6-48b1-834a-d704656085c4
Public Version Date
August 07, 2020
Public Version Number
6
DI Record Publish Date
November 16, 2016
Package DI Number
10311917186273
Quantity per Package
24
Contains DI Package
00311917186276
Package Discontinue Date
November 21, 2016
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |