Duns Number:081049410
Device Description: Personal Lubricant
Catalog Number
-
Brand Name
KY Touch 2-in-1 Massage Creme & Pleasure Gel
Version/Model Number
Personal Lubricant
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
-
Product Code
NUC
Product Code Name
Lubricant, personal
Public Device Record Key
1a2a1c22-a669-4989-8313-5e94fd52b6ca
Public Version Date
December 13, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10067981962168
Quantity per Package
4
Contains DI Package
00067981962161
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 24 |