Duns Number:067692292
Device Description: Silicone-Based Personal Lubricant
Catalog Number
-
Brand Name
JO Premium Anal - Original - Lubricant 2 floz / 60 mL
Version/Model Number
40102
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)
Yes
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
K180083,K180083
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
f41ca8b5-7d66-4210-b7e4-4668e129a6ba
Public Version Date
September 21, 2022
Public Version Number
1
DI Record Publish Date
September 13, 2022
Package DI Number
10796494000462
Quantity per Package
12
Contains DI Package
00796494000465
Package Discontinue Date
-
Package Status
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 |