FDA.reportPublic FDA data

SKYN

Primary DI
08859798100889
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
08859798100889
Device description
SKYN ELITE 12CT + 1 NATURALLY ENDLESS SACHET
Published
2023-09-19
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
08859798100889PrimaryGS10
18859798100886Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859798100889088597981008898859798100889
1885979810088618859798100886

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
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

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Primary DI, Brand, Company table
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00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
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