FDA.reportPublic FDA data

SKYN

Primary DI
08859798100360
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
08859798100360
Device description
SKYN NATURALLY ENDLESS 8.5fl oz (250ml)
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221243000OFNat Lubricant (L15)Suretex Limited2022-09-30NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859798100360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859798100360088597981003608859798100360

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
848-229-3224alexandra.kirkland@lifestyles.com

Regulatory Flags#

DUNS number
672044515
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859798108670skyn088597981086702026-09-18
08859798108687SKYN088597981086872026-09-18
08859798108694SKYN088597981086942026-09-18
08859798108700SKYN088597981087002026-09-18
08859798108717SKYN088597981087172026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859798108670skynSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108687SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108694SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108700SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
08859798108717SKYNSURETEX LIMITED - BRANCHNUC2026-09-18
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