FDA.reportPublic FDA data

SKYN

Primary DI
00070907254158
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
5415
Device description
SKYN ELITE 22CT
Published
2017-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom
MOLCondom, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2
MOLCondom, SyntheticObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070800000
K171172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070800000LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOMAnsell Healthcare Products, LLC2008-03-06MOL
K171172000Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC2017-08-02MOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070907254155PackageGS14In Commercial Distribution
30070907254159PackageGS16In Commercial Distribution
00070907254158PrimaryGS10
80070907695681Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007090725415510070907254155
3007090725415930070907254159
00070907254158000709072541580709072541580070907254158
8007090769568180070907695681

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8482293224alexandra.kirkland@lifestyles.com

Regulatory Flags#

DUNS number
672044515
Device count
22
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
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
18859798108066SKYN088597981080692026-01-13
18859798108073LIFESTYLES088597981080762026-01-13
18859798108080LIFESTYLES088597981080832026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120365One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120730One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120747One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120778One Unity CollectionGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
00302340996136Durex IntenseRECKITT BENCKISER LLCMOL2026-03-02
00302340995825Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340995993Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996006Durex Intense XLRECKITT BENCKISER LLCMOL2025-09-01
00302340996013Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340996020Durex Intense Ultra LubeRECKITT BENCKISER LLCMOL2025-09-01
00302340096584DUREX Intense Sensation CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340300452DUREX Classic CondomRECKITT BENCKISER LLCHIS2025-05-14
00302340995696DUREX® Adventure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340300421DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20
00302340989336DUREX® Pleasure PackRECKITT BENCKISER LLCHIS2025-03-20
00067981087970DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00067981087987DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00067981087994DUREX® Air Regular Fit; DUREX® AirRECKITT BENCKISER LLCHIS2025-03-13
00302340090001DUREX Tropical CondomsRECKITT BENCKISER LLCHIS2025-03-13