Duns Number:079690693
Device Description: Sylk Personal Lubricant is an intimate moisturizer made with the vine extract of the New Z Sylk Personal Lubricant is an intimate moisturizer made with the vine extract of the New Zealand kiwifruit plant harvested from orchards in the Province of Auckland, New Zealand. Through a proprietary extraction process, the natural film‐like lubricant is collected, the composition of which is similar to that of what the body produces. Sylk Personal Lubricant is formulated to be a non‐sterile, non‐greasy, non‐sticky, non‐staining, viscous liquid with a pH range of 4.4 to 4.7 to match the vaginal region for the majority of a women’s cycle. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes.
Catalog Number
-
Brand Name
Sylk
Version/Model Number
Toro 100
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
K152646
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
9d5b24a6-cc6b-4cf3-9d74-09f3324904b0
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
November 27, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |