FDA.reportPublic FDA data

Lubrigyn Cream

Primary DI
00186977000295
Brand
Lubrigyn Cream
Company
UNIDERM FARMACEUTICI SRL
Model
50 ml
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K150147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150147000Lubrigyn creamUniderm Farmaceutici Srl2015-02-19NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00186977000295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00186977000295001869770002951869770002950186977000295

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429512247
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
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
06979879080366RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080373HANIDOLLShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080380TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080397Wet StuffShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
00860002995304HYDRADOSEMD LABS LLCNUC2026-08-01
06936684210333S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210340S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210357S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
00855859003319ViaSolv Wellness, LLCNUC2026-07-29
00850026643275Rock CandyPRIVATE LABEL PRODUCTIONS LLCNUC2026-07-17