FDA.reportPublic FDA data

Lifestyles

Primary DI
00850002174038
Brand
Lifestyles
Company
LUNAMAX LLC
Model
GS100B
Device description
Lifestyles SKYN Polyisoprene/Synthetic Condom
Published
2018-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
00850002174038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002174038008500021740388500021740380850002174038

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
106855461
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002174014LifestylesGS1102019-01-16
00850002174083LifestylesGS1112019-01-16
00850002174106CrownGS2102019-01-16
00850002174113CrownGS2112019-01-16
00850002174137LifestylesGS1052019-01-16
00850002174502LifestylesGS110B2019-01-16
00850002174519Beyond SevenGS1802019-01-16
00850002174526Beyond SevenGS180B2019-01-16
00850002174533Beyond SevenGS1812019-01-16
00850002174540Beyond SevenGS181B2019-01-16
00850002174656ONEGS1412019-01-16
00850002174670TrustexGS1742019-01-16
00850002174694TrustexGS1752019-01-16
00850002174793LifestylesGS105B2019-01-16
00850002174823TrustexGS1602019-01-16
00850002174830TrustexGS1612019-01-16
00850002174847TrustexGS1642019-01-16
00850002174854TrustexGS1652019-01-16
00850002174861TrustexGS1662019-01-16
00850002174878TrustexGS1682019-01-16

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