Home GUDID 00868371000209 Sylk
Primary DI 00868371000209
Brand Sylk
Company TORO MANAGEMENT LLC
Model Toro 100
Device description 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.
Published 2018-11-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name NUC Lubricant, Personal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUC Lubricant, Personal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00868371000209 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00868371000209 00868371000209 868371000209 0868371000209
GMDN Terms# Term, Definition table Term Definition Sexual lubricant A non-sterile substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 3 Fluid Ounce
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