FDA.reportPublic FDA data

pjur Backdoor water-based

Primary DI
00827160112271
Brand
pjur Backdoor water-based
Company
Pjur Group Luxembourg SA
Model
pjur backdoor waterbased 250 ml - USA
Catalog number
12880-02
Device description
Water-based Personal Lubricant with Hyaluron
Published
2018-05-08
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010199000
K200527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010199000PJUR EROS WATER FORMULATIONL.C.C. Pjur Group Germany2001-04-05NUC
K200527000pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjurPjur Group Luxembourg S.A.2021-02-19NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827160112278PackageGS14In Commercial Distribution
40827160112279PackageGS112In Commercial Distribution
00827160112271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082716011227810827160112278
4082716011227940827160112279
00827160112271008271601122718271601122710827160112271

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
400744553
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827160117238pjur TOY GLIDEpjur TOY GLIDE 5 ml - USA14098-022026-04-21
00827160116866pjur TOY GLIDEpjur TOY GLIDE 100 ml - USA14070-022025-05-23
00827160115012pjur ORIGINAL Sachetcard 2021, 1,5ml USApjur ORIGINAL Sachetcard 2021, 1,5ml USA2021-07-23
00827160112110pjur MAN Waterpjur MAN Water 100 ml - USA2018-12-04
40827160116864pjur TOY GLIDEpjur TOY GLIDE 100 ml - USA14070-022025-05-23
00827160116774pjur BACK DOOR Relaxingpjur BACK DOOR Relaxing 30ml - USA14062-022025-04-16
00827160116781pjur BACK DOOR Moisturizingpjur BACK DOOR Moisturizing 30ml - USA14063-022025-04-16
00827160116750pjur analyse me! Relaxing, 1,5 ml USApjur analyse me! Relaxing, 1,5ml USA (50 pcs)14060-022025-04-16
10827160116771pjur BACK DOOR Relaxingpjur BACK DOOR Relaxing 30ml - USA14062-022025-04-16
10827160116788pjur BACK DOOR Moisturizingpjur BACK DOOR Moisturizing 30ml - USA14063-022025-04-16
00827160114350pjur analyse me! Moisturizing glidepjur analyse me! Moisturizing 10 ml - USA (50 pcs.13780-02 2025-04-10
00827160116767pjur AQUA Nakedpjur AQUA Naked, 30ml USA14061-022025-03-24
10827160116764pjur AQUA Nakedpjur AQUA Naked, 30ml USA14061-022025-03-24
00827160114367pjur WOMAN Nudepjur WOMAN Nude 10 ml - USA13790-02 2024-05-23
00827160116279pjur med HYDROpjur med HYDRO 2 ml - USA 14026-022024-04-30
00827160116286pjur med SENSITIVEpjur med SENSITIVE 2ml - USA 14027-022024-04-30
00827160116293pjur AQUA Naturalpjur AQUA Natural 2ml - USA14028-022024-04-30
10827160116276pjur med HYDROpjur med HYDRO 2 ml - USA 14026-022024-04-30
10827160116283pjur med SENSITIVEpjur med SENSITIVE 2ml - USA 14027-022024-04-30
10827160116290pjur AQUA Naturalpjur AQUA Natural 2ml - USA14028-022024-04-30

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