Duns Number:153909531
Catalog Number
500102
Brand Name
Good Clean Love Restore
Version/Model Number
2oz.
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
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
K162207,K162207
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
c156373b-c3bb-4618-918c-82cc43a0ec60
Public Version Date
April 13, 2022
Public Version Number
4
DI Record Publish Date
September 25, 2017
Package DI Number
30893268000742
Quantity per Package
72
Contains DI Package
00893268000222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |