FDA.reportPublic FDA data

LifeStyles SKYN Original 40 ct Bowl

Primary DI
00813356000200
Brand
LifeStyles SKYN Original 40 ct Bowl
Company
PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
Model
813356000200
Published
2018-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K160399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160399000Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC2016-07-25MOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813356000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813356000200008133560002008133560002000813356000200

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

Regulatory Flags#

DUNS number
038573838
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813356005014Crown Lubricated 500 ct Bag8133560050142025-11-11
00813356005069Crown Lubricated 250 ct Bag8133560050692025-11-11
00813356005137Kimono Bowl Microthin 40 ct Bowl8133560051372025-11-11
00813356005205Crown Lubricated 100 ct Bag8133560052052025-11-11
00813356005120Kimono Bowl Maxx Large Flare 40 ct Bowl8133560051202025-10-17
00813356005175Kimono Bowl Special 40 ct Bowl8133560051752025-10-17
00813356000064Lifestyles SKYN Elite 40 ct Bowl8133560000642025-09-11
00813356005380Paradise Super Thin 100 Condom704102025-09-05
00813356000040Paradise Slim Fit Condoms Strips 1000s706002019-07-08
00813356000057Paradise Slim Fit Condoms 40 ct bowl8133560000572019-07-08
00813356005366Paradise Super Thin 1000 Condom704002025-01-22
00813356000118Astroglide Personal Lubricant 40 ct bowl8133560001182018-12-21
00813356000002Paradise Lubricated Condoms Strips 1000s701002018-12-21
00813356000019Paradise Lubricated Condoms 40 ct bowl8133560000192018-12-21
00813356000033Lifestyles Rough Rider Studded 40 ct Bowl8133560000332019-04-23
00813356000125Trojan Enz 40 ct Bowl8133560001252019-02-11
00813356000132Trojan Magnum 40 ct Bowl8133560001322019-02-11
00813356000026Lover Covers Condoms 40 ct bowl8133560000262018-12-21
00813356000156Lifestyles Assorted Colors 40 ct Bowl8133560001562018-12-21
00813356000163LifeStyles Assorted Flavors 40 ct Bowl8133560001632018-12-21

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