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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152646000SYLK PERSONAL LUBRICANTToro Management, LLC Dba Sylk2016-03-11NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868371000209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868371000209008683710002098683710002090868371000209

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA 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
TypeValueUnit
Total Volume3Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-795-5872info@sylkusa.com

Regulatory Flags#

DUNS number
079690693
Device count
1
Lot or batch
true
Expiration date on label
true

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