FDA.reportPublic FDA data

Evoke

Primary DI
00092006001150
Brand
Evoke
Company
GUY & O'NEILL, INC.
Model
900-050
Device description
5oz Personal Lubricant
Published
2018-05-07
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
K160763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160763000ally Liquid Personal LubricantPrivate Label Production, LLC2016-06-29NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092006001150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092006001150000920060011500920060011500092006001150

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
262-447-3101customerservice@guyandoneill.com

Regulatory Flags#

DUNS number
037838844
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092006001075Evoke900-0252017-04-19
00681131156066Equate900-0502017-04-19

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Primary DI, Brand, Company table
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