FDA.reportPublic FDA data

Smile Makers

Primary DI
08859350704111
Brand
Smile Makers
Company
MEIYUME MANUFACTURING (THAILAND) LIMITED
Model
60 ml
Device description
Personal lubricant
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K182100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182100000Smile Makers Personal LubricantLfbeauty (Thailand) Limited2019-04-25NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859350704118PackageGS112In Commercial Distribution
28859350704115PackageGS16In Commercial Distribution
08859350704111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885935070411818859350704118
2885935070411528859350704115
08859350704111088593507041118859350704111

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
Special Storage Condition, Specify00Store at room temperature. Avoid exposure to direct sunlight.

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
660728606
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28859350704115Smile Makers60 ml2024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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