FDA.reportPublic FDA data

Epw - Lions Den Water Based Lube - Unscented - 8Oz

Primary DI
00850062204003
Brand
Epw - Lions Den Water Based Lube - Unscented - 8Oz
Company
Solevy Co., LLC
Model
907073
Device description
Water-Based Personal Lubricant
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850062204000PackageGS112In Commercial Distribution
00850062204003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006220400010850062204000
00850062204003008500622040038500622040030850062204003

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.

Regulatory Flags#

DUNS number
056875098
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062204034Epw - Lions Den Silicone Lube - Unscented - 4Oz9074942024-06-03
10850062204000Epw - Lions Den Water Based Lube - Unscented - 8Oz9070732024-06-03
00850062204010Epw - Lions Den Water Based Lube - Unscented - 4Oz9070712024-06-03
00850062204027Epw - Lions Den Water Based Lube - Unscented - 2Oz9070722024-06-03
10850062204031Epw - Lions Den Silicone Lube - Unscented - 4Oz9074942024-06-03

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