FDA.reportPublic FDA data

überlube

Primary DI
00851674003176
Brand
überlube
Company
UBERLUBE LLC
Model
UBER-15B
Catalog number
UBER-15B
Device description
Good-to-Go Black
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00851674003176PackageGS112In Commercial Distribution
10851674003128PackageGS112In Commercial Distribution
00851674003121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851674003176008516740031768516740031760851674003176
1085167400312810851674003128
00851674003121008516740031218516740031210851674003121

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA non-sterile 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. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010211719
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
false
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
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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Primary DI, Brand, Company table
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00199284921726Urge Silicone Personal LubricantUrge Cream LLCNUC2026-07-08
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
06979879080236ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080250ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080267ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080298Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080304Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080311TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080328TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080342SyronosShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
00796494006191Kindra - Water-based Lubricant - 3.4ozCC Wellness LLCNUC2026-06-10
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.NUC2026-06-04
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8ozCC Wellness LLCNUC2026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8ozCC Wellness LLCNUC2026-06-02
00796494404089JO Cumplay 4ozCC Wellness LLCNUC2026-06-02
00087701190797good neighbor pharmacyAmerisourcebergen Drug CorporationNUC2026-06-01
00787651760643AZOi-Health, Inc.NUC2026-05-29
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
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