FDA.reportPublic FDA data

SKYN

Primary DI
00070907001134
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
0113
Device description
SKYN ORIGINAL 24CT + 1 NATURALLY ENDLESS SACHET
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOLCondom, Synthetic
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOLCondom, SyntheticObstetrics/Gynecology2
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171172000
K221243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171172000Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC2017-08-02MOL
K221243000OFNat Lubricant (L15)Suretex Limited2022-09-30NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070907001131PackageGS14In Commercial Distribution
30070907001135PackageGS124In Commercial Distribution
00070907001134PrimaryGS10
80070907102165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007090700113110070907001131
3007090700113530070907001135
00070907001134000709070011340709070011340070907001134
8007090710216580070907102165

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, synthetic polymerA sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
848-229-3224alexandra.kirkland@lifestyles.com

Regulatory Flags#

DUNS number
672044515
Device count
13
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859798108953SKYN088597981089532026-06-25
08859798108960LIFESTYLES088597981089602026-06-25
08859798108977LIFESTYLES088597981089772026-06-25
08859798108526SKYN088597981085262026-04-30
08859798108533SKYN088597981085332026-04-30
08859798108540SKYN088597981085402026-04-30
08859798108632SKYN088597981086322026-04-30
08859798108724SKYN088597981087242026-04-30
08859798108465SKYN088597981084652026-03-12
08859798108472SKYN088597981084722026-03-12
08859798108496SKYN088597981084962026-03-12
18859798108462SKYN088597981084652026-03-12
18859798108479SKYN088597981084722026-03-12
18859798108493SKYN088597981084962026-03-12
08859798108090LIFESTYLES088597981080902026-01-27
18859798108097LIFESTYLES088597981080902026-01-27
08859798108441SKYN088597981084412026-01-27
08859798108069SKYN088597981080692026-01-13
08859798108076LIFESTYLES088597981080762026-01-13
08859798108083LIFESTYLES088597981080832026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850026643275Rock CandyPRIVATE LABEL PRODUCTIONS LLCNUC2026-07-17
00198715540161LavaLava IntimatesNUC2026-07-14
06974586081675BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-07-14
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
08859798108953SKYNSURETEX LIMITED - BRANCHMOL2026-06-25
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
00302340996136Durex IntenseRECKITT BENCKISER LLCMOL2026-03-02
00067981089127KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981089486KY Warming JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRECKITT BENCKISER LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRECKITT BENCKISER LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRECKITT BENCKISER LLCNUC2025-12-09