FDA.reportPublic FDA data

SKYN

Primary DI
00070907273241
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
7324
Device description
SKYN ORIGINAL 24CT
Published
2016-07-11
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10070907273248PackageGS14In Commercial Distribution
30070907273242PackageGS16In Commercial Distribution
00070907273241PrimaryGS10
80070907695667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007090727324810070907273248
3007090727324230070907273242
00070907273241000709072732410709072732410070907273241
8007090769566780070907695667

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
24
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
08859798108526SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108533SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108540SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108632SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108724SKYNSURETEX LIMITED - BRANCHMOL2026-04-30
08859798108465SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108472SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
08859798108496SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108462SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108479SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
18859798108493SKYNSURETEX LIMITED - BRANCHMOL2026-03-12
00302340996136Durex IntenseRB Health (us) LLCMOL2026-03-02
50302340996131Durex IntenseRB Health (us) LLCMOL2026-03-02
08859798108441SKYNSURETEX LIMITED - BRANCHMOL2026-01-27
08859798108069SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
18859798108066SKYNSURETEX LIMITED - BRANCHMOL2026-01-13
08859798107888SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107895SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107949SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107963SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798107970SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108021SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108038SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108045SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798108052SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
18859798107885SKYNSURETEX LIMITED - BRANCHMOL2025-12-16
08859798106973SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107307SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107314SKYNSURETEX LIMITED - BRANCHMOL2025-09-04
08859798107321SKYNSURETEX LIMITED - BRANCHMOL2025-09-04