FDA.report

SKYN

Primary DI
08859798100599
Brand
SKYN
Company
SURETEX LIMITED - BRANCH
Model
08859798100599
Device description
SKYN NATURAL CHEMISTRY PERSONAL LUBRICANT 2.7oz (80ml)
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NUCLubricant, Personal

Product Code Classifications

CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08859798100599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08859798100599088597981005998859798100599

GMDN Terms

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

Contacts

PhoneEmail
848-229-3224alexandra.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 DIBrandModelCatalogPublished
18859798108462SKYN088597981084652026-03-12
18859798108479SKYN088597981084722026-03-12
18859798108493SKYN088597981084962026-03-12
18859798108097LIFESTYLES088597981080902026-01-27
08859798108441SKYN088597981084412026-01-27
18859798108066SKYN088597981080692026-01-13
18859798108073LIFESTYLES088597981080762026-01-13
18859798108080LIFESTYLES088597981080832026-01-13
18859798107885SKYN088597981078882025-12-16
18859798107892SKYN088597981078952025-12-16
18859798107946SKYN088597981079492025-12-16
18859798107960SKYN088597981079632025-12-16
18859798107977SKYN088597981079702025-12-16
28859798108025SKYN088597981080212025-12-16
18859798108035SKYN088597981080382025-12-16
28859798108049SKYN088597981080452025-12-16
28859798108056SKYN088597981080522025-12-16
18859798107878LIFESTYLES088597981078712025-12-03
28859798106977SKYN088597981069732025-09-04
18859798107267LIFESTYLES088597981072602025-09-04

Other Devices Sharing Product Codes

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00850012528463JoyluxJoylux, Inc.NUC2026-03-23
10860015340037Sugah Lipz Pina ColadaSUGAH LIPZ, INCNUC2026-03-14
10860015340044Sugah Lipz VanillaSUGAH LIPZ, INCNUC2026-03-13
06977552380567Satin Gel Strawberry flavor human lubricantShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-03-12
06977552380574Satin Gel Vitamin E human lubricantShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-03-12
06977552380581Satin Gel Peach flavored human lubricantShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-03-12
06977552380598Satin Gel Caramel flavored human lubricantShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-03-12
00860012900411First ReleaseBath Concept Cosmetics (DongGuan) Co., Ltd.NUC2026-03-10
00194346600793Equate Liquid Personal LubricantWAL-MART STORES, INC.NUC2026-02-28
00194346600809Equate Liquid Personal LubricantWAL-MART STORES, INC.NUC2026-02-28
00194346600816Equate Jelly Personal LubricantWAL-MART STORES, INC.NUC2026-02-28
00194346600823Equate Jelly Personal LubricantWAL-MART STORES, INC.NUC2026-02-28
00761236902604FAVWESTRIDGE LABORATORIES INCORPORATEDNUC2026-02-11
00761236903571FAVWESTRIDGE LABORATORIES INCORPORATEDNUC2026-02-11
10860015384406Gold Lion Water-Base 4ozJAD PARTNERS CORP.NUC2026-02-10
10860015384413Gold Lion Water-Base 8ozJAD PARTNERS CORP.NUC2026-02-10
90761236902591FAVWESTRIDGE LABORATORIES INCORPORATEDNUC2026-02-09
00848518064677Jock Rimming Lubricant – Cherry – 8ozXR, LLCNUC2026-02-09
00848518064684Jock Anal Lubricant – 8ozXR, LLCNUC2026-02-09
00848518064691PA Anal Lubricant – 8ozXR, LLCNUC2026-02-09
00848518064707Creamy Hybrid 8ozXR, LLCNUC2026-02-09
30860015340000Sugah Lipz StrawberrySUGAH LIPZ, INCNUC2026-02-06
10860015340013Sugah Lipz Green AppleSUGAH LIPZ, INCNUC2026-02-06
10860015340020Sugah Lipz PeachSUGAH LIPZ, INCNUC2026-02-06
06974586081231Tracy's Dog, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-01-29
06974586081309Bestvibe, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-01-29
06974586081316Bestvibe, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-01-29
06974586081323Mrgras, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-01-29
06974586081330GOYha, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-01-29