FDA.reportPublic FDA data

SKYN

Primary DI
00070907001080
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
0108
Device description
SKYN ELITE 12CT + 1 NATURALLY ENDLESS SACHET
Published
2023-06-26
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
10070907001087PackageGS14In Commercial Distribution
30070907001081PackageGS124In Commercial Distribution
00070907001080PrimaryGS10
08007090710217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007090700108710070907001087
3007090700108130070907001081
00070907001080000709070010800709070010800070907001080
08007090710217080070907102178007090710217

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
13
Kit
true
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
08859798109585SKYN088597981095852026-10-26
08859798109592LIFESTYLES088597981095922026-10-26
08859798109608SKYN088597981096082026-10-26
08859798109615SKYN088597981096152026-10-26
08859798109622SKYN088597981096222026-10-26
08859798109639SKYN088597981096392026-10-26
08859798109646SKYN088597981096462026-10-26
08859798109653SKYN088597981096532026-10-26
08859798109660SKYN088597981096602026-10-26
08859798108670SKYN088597981086702026-09-18
08859798108687SKYN088597981086872026-09-18
08859798108694SKYN088597981086942026-09-18
08859798108700SKYN088597981087002026-09-18
08859798108717SKYN088597981087172026-09-18
08859798100322LIFESTYLES088597981003222023-09-14
08859798100155SKYN088597981001552023-09-14
08859798100209SKYN088597981002092023-09-14
08859798100421SKYN088597981004212023-09-15
08859798100919SKYN088597981009192023-09-22
08859798101282SKYN088597981012822023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016593107Cock Oil Water Based Lubricant Paraben Free 2 oz TubeCockOil LLCNUC2026-10-27
00860016593114Cock Oil Water Based Lubricant Paraben Free 7.5 oz Foil PacketCockOil LLCNUC2026-10-27
00860016593121Cock Oil Silicone Lubricant 9 oz Pump and Pour BottleCockOil LLCNUC2026-10-27
08859798109585SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109608SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109615SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109622SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109639SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109646SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109653SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
08859798109660SKYNSURETEX LIMITED - BRANCHMOL2026-10-26
00884400733139JetlustFrisk LLCNUC2026-10-21
00726893119949One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119956One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00726893119970One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
20726893120123One TrueGLOBAL PROTECTION CORP.NUC2026-10-07
00860014736827King's Gear Water Based Lube 8 floz / 240 MLLSTX LLCNUC2026-10-01
00850012528593JUICY LIKE A PEACHJoylux, Inc.NUC2026-09-29
00796494750261LL 3x Anal 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
00796494750278LL Silky Silicone 5mL Foils - 10pkCC Wellness LLCNUC2026-09-24
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
00199874950815Hyaluronic Acid Vaginal Suppository (HA 10 mg)HUDI PHARMA SRLNUC2026-09-06
00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
00796494750223LL Water-Based 5mL Foil - 10pkCC Wellness LLCNUC2026-09-04
00796494750230LL 3X Anal 5mLCC Wellness LLCNUC2026-09-04
00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04