FDA.reportPublic FDA data

SKYN

Primary DI
08859798108700
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
08859798108700
Device description
SKYN SILICONE LUBRICANT 8oz
Published
2026-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859798108700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859798108700088597981087008859798108700

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.

Contacts#

Phone, Email table
PhoneEmail
8482293224alexandra.kirkland@lifestyles.com

Regulatory Flags#

DUNS number
672044515
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08859798108717SKYN088597981087172026-09-18
08859798100322LIFESTYLES088597981003222023-09-14
08859798100155SKYN088597981001552023-09-14
08859798100209SKYN088597981002092023-09-14
08859798100421SKYN088597981004212023-09-15
08859798100919SKYN088597981009192023-09-22
08859798101282SKYN088597981012822023-09-28
08859798106058LIFESTYLES088597981060582025-06-18

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
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
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
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
00651277000004Cock Oil Foil Packet water baseCockOil LLCNUC2026-08-24
00651277001681Cock Oil - Silicone 9ozCockOil LLCNUC2026-08-21
00651277069001Cock Oil - Natural Agape 2ozCockOil LLCNUC2026-08-21
06974586081637BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-08-19
06979879080199RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080205RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080212RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080229RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14