Sylk

GUDID 00868371000209

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.

TORO MANAGEMENT LLC

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant

• Primary Device ID: 00868371000209
• NIH Device Record Key: 9d5b24a6-cc6b-4cf3-9d74-09f3324904b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sylk
• Version Model Number: Toro 100
• Company DUNS: 079690693
• Company Name: TORO MANAGEMENT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com
• Phone: 855-795-5872
• Email: info@sylkusa.com

Device Dimensions

• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce
• Total Volume: 3 Fluid Ounce

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868371000209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152646

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-28
• Device Publish Date: 2018-11-27