FDA.reportPublic FDA data

überlube

Primary DI
00851674003114
Brand
überlube
Company
UBERLUBE LLC
Model
UBER-30RF+30RF
Catalog number
UBER-30RF+30RF
Device description
Good-To-Go Refills + Refills
Published
2016-10-03
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151647000UberlubeUberlube, LLC2015-09-23NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851674003111PackageGS16Not in Commercial Distribution
00851674003114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167400311110851674003111
00851674003114008516740031148516740031140851674003114

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
010211719
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851674003220überlubeUBER-15GUBER-15G2025-04-28
00851674003244überlubeUBER-15RUBER-15R2025-04-28
00851674003268überlubeUBER-15PUBER-15P2025-04-28
00851674003275überlubeUBER-15BLUBER-15BL2025-04-28
00851674003282überlubeUBER-15AQUBER-15AQ2025-04-28
00851674003299überlubeUBER-15WHUBER-15WH2025-04-28
00851674003398überlubeUBER-15ORUBER-15OR2025-04-28
00851674003435überlubeUBER-15PRUBER-15PR2025-04-28
00851674003466überlubeUBER-15GRUBER-15GR2025-04-28
10851674003227überlubeUBER-15GUBER-15G2025-04-28
10851674003241überlubeUBER-15RUBER-15R2025-04-28
10851674003265überlubeUBER-15PUBER-15P2025-04-28
10851674003272überlubeUBER-15BLUBER-15BL2025-04-28
10851674003289überlubeUBER-15AQUBER-15AQ2025-04-28
10851674003296überlubeUBER-15WHUBER-15WH2025-04-28
10851674003395überlubeUBER-15ORUBER-15OR2025-04-28
10851674003432überlubeUBER-15PRUBER-15PR2025-04-28
10851674003463überlubeUBER-15GRUBER-15GR2025-04-28
00851674003008überlubeUBER-50UBER-502016-10-03
00851674003091überlubeUBER-15S+30RFUBER-15S+30RF2016-10-03

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