FDA.reportPublic FDA data

Signature Care

Primary DI
20321130780247
Brand
Signature Care
Company
BETTER LIVING BRANDS LLC
Model
7W926LJC3
Device description
Personal Lubricating Jelly 4oz. (113g)
Published
2022-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K012203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012203000CLAY-PARK LABS, INC. - LUBRICATING JELLYClay-Park Labs, Inc.2001-08-27NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20321130780247PackageGS16In Commercial Distribution
30321130780244PackageGS172In Commercial Distribution
00321130780243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032113078024720321130780247
3032113078024430321130780244
00321130780243003211307802433211307802430321130780243

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
080349866
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00021130794461Signature CareSAF4025RSAF4025R2026-07-16
00321130762843Signature Care3211307628432020-08-10
00321130762850Signature Care3211307628502020-08-10
00321130788812Signature Care3211307888122020-07-31
00321130144724Signature Care3211301447242020-07-31
00321130078210Signature Care3211300782102020-07-31
00321130211419Signature Select3211302114192025-10-02
00321130211426Signature Select3211302114262025-10-02
00021130163830Signature Care Digital Pregnancy Test2021-04-16
00321130352945Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130163823Signature Care One Step Pregnancy Test2021-04-16
00321130195900Signature Care321130195900X004JE7MZP2022-12-12
00321130351115AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130351112AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130352942Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130790005Signature Care Early Result Pregnancy Test2016-10-26
00321130195894Signature Care3211301958942022-12-12
10321130195891Signature Care3211301958942022-12-12
10321130195907Signature Care3211301959002022-12-12
00321130780595Safeway Facemask SAF384RSAF384R2016-09-24

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Primary DI, Brand, Company table
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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
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06979879080199RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
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00198715540161LavaLava IntimatesNUC2026-07-14
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00199284921726Urge Silicone Personal LubricantUrge Cream LLCNUC2026-07-08
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
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