FDA.reportPublic FDA data

THE HONEYPOT COMPANY

Primary DI
00851669008261
Brand
THE HONEYPOT COMPANY
Company
The Honey Pot Company De LLC
Model
8261
Device description
Our 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
2019-02-07
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
00851669008261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851669008261008516690082618516690082610851669008261

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
(866) 597-9547SUPPORT@THEHONEYPOT.CO

Regulatory Flags#

DUNS number
045600502
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851669008551The Honey Pot CompanyF85512023-03-30
00851669008568The Honey Pot CompanyF85682023-03-30
00851669008629The Honey Pot CompanyF86292023-04-07
00850021589004The Honey Pot CompanyF90042023-03-30
00850021589011The Honey Pot CompanyF90112023-03-30
00850021589707The Honey Pot CompanyF97072023-03-30
00851669008513The Honey Pot CompanyF8153-BPA2023-08-23
00851669008520The Honey Pot CompanyF8520-BPA2023-08-23
00851669008896The Honey Pot CompanyF88962023-05-23
00851669008902The Honey Pot CompanyF89022023-05-23
00851669008926The Honey Pot CompanyF89262023-04-07

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Primary DI, Brand, Company table
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