FDA.reportPublic FDA data

Pink

Primary DI
20891306000092
Brand
Pink
Company
Empowered Products, Inc.
Model
Silicone - 4oz
Device description
4oz glass bottle of silicone based lubricant intended for use during intercourse or masturbation.
Published
2022-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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
K152918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152918000Gun Oil, Pink, Gun Oil H2O, Pink WaterEmpowered Products, Inc.2016-06-02NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20891306000092PackageGS18In Commercial Distribution
00813362024139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089130600009220891306000092
00813362024139008133620241398133620241390813362024139

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA 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. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(702) 216-1321helpdesk@empoweredproducts.com

Regulatory Flags#

DUNS number
784316213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813362024139PinkSilicone - 4oz2022-02-09
00813362024146PinkWater - 4oz2022-02-09
00891306000074Gun OilSilicone - 8oz2022-02-09
00891306000166PinkSilicone - Sample2022-02-09
00891306000173Gun OilH2O - 2oz2022-02-09
00891306000180Gun OilH2O - 4oz2022-02-09
00891306000197Gun OilH2O - 8oz2022-02-09
00891306000203Gun OilH2O - Sample2022-02-09
00891306000210Gun OilSilicone - Sample2022-02-09
00891306000227Gun OilSilicone - 16oz2022-02-09
00891306000234Gun OilH2O - 16oz2022-02-09
00891306000296Gun OilSilicone - 32oz2022-02-09
00891306000302Gun OilH2O - 32oz2022-02-09
00891306000418PinkWater - 4.7oz2022-02-09
00891306000456PinkSilicone - 2.8oz2022-02-09
00891306000463PinkWater - 2.8oz2022-02-09
00891306000661PinkWater - Sample2022-02-09
00891306000968PinkWater - 8oz2022-02-09
10891306000903PinkWater - 4oz2022-02-09
00891306000036Gun OilSilicone - 2oz2022-02-09

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