FDA.reportPublic FDA data

Maude - Shine Silicone Personal Lubricant 8 oz

Primary DI
00860773000436
Brand
Maude - Shine Silicone Personal Lubricant 8 oz
Company
Maude Group, Inc.
Model
55762
Catalog number
MD-SHNS-8
Device description
This is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Published
2024-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10860773000433PackageGS11In Commercial Distribution
20860773000430PackageGS16In Commercial Distribution
00860773000436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086077300043310860773000433
2086077300043020860773000430
00860773000436008607730004368607730004360860773000436

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079744051
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855770008448Maude - Shine Silicone Personal Lubricant 4 oz55765MD-SHNS-42024-05-02
00860773000474Maude - Shine Silicone Personal Lubricant 2oz55761MD-SHNS-22024-05-02
10855770008445Maude - Shine Silicone Personal Lubricant 4 oz55765MD-SHNS-42024-05-02
10860773000471Maude - Shine Silicone Personal Lubricant 2oz55761MD-SHNS-22024-05-02
00860773000481Maude - Shine Organic Aloe Based Lubricant 2 oz55763MD-SHNO-22024-04-25
10860773000488Maude - Shine Organic Aloe Based Lubricant 2 oz55763MD-SHNO-22024-04-25
00860773000429Maude - Shine Organic Aloe Based Lubricant 8 oz55764MD-SHNO-82024-03-09
00855770008431Maude - Shine Organic Aloe Based Lubricant 4 oz55767MD-SHNO-42024-03-09
10860773000426Maude - Shine Organic Aloe Based Lubricant 8 oz55764MD-SHNO-82024-03-09
00860009043411Maude - Heat, Warming Lubricant 4ozMD-HEAT-12023-12-06

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