Duns Number:067692292
Device Description: Water-based Personal Lubricant
Catalog Number
-
Brand Name
JO Gelato Mint Chocolate 1oz/30ml
Version/Model Number
41022
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2018
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
2d49b777-7b13-409f-9484-d3fdb895d72b
Public Version Date
September 09, 2022
Public Version Number
10
DI Record Publish Date
May 21, 2018
Package DI Number
B362410221
Quantity per Package
12
Contains DI Package
B362410220
Package Discontinue Date
August 17, 2018
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 199 |