FDA.reportPublic FDA data

Restore Moisturizing Vaginal Gel

Primary DI
30850014621477
Brand
Restore Moisturizing Vaginal Gel
Company
GOOD CLEAN LOVE, INC.
Model
2 oz
Catalog number
900300
Device description
Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Published
2021-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850014621477PackageGS124In Commercial Distribution
00850014621476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001462147730850014621477
00850014621476008500146214768500146214760850014621476

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, non-sterileA non-sterile substance intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5413444483info@goodcleanlove.com

Regulatory Flags#

DUNS number
153909531
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
00850014621070Rehydrate Vaginal Gel5 mL2006012022-04-14
00893268000673Regenesis Fertility Lubricant2oz2004022022-04-12
00893268000680Rehydrate Vaginal Gel2oz2006022022-04-14
00893268000802Regenesis Fertility Lubricant5mL2004012023-04-03
00850044065172Naked Coconut1.5oz7006502025-06-24
00850044065219Naked Coconut3ozE700750, C7007502025-06-24
00893268000253BioNude Ultra Sensitive Personal Lubricant3oz2007042022-04-12
00893268000604Almost Naked4oz.2001042016-10-13
00893268000222Restore Moisturizing Vaginal Gel2oz.5001022017-09-25
00893268000109Almost Naked1.5oz.2001052016-10-13
00850014621773Liquid Lubricant5 mL2005002022-05-18
00850014621780Hybrid Lubricant5 mL2005012022-05-18
00893268000260BioNude Ultra Sensitive Personal Lubricant5 mL2007052022-04-12
00893268000710Restore Moisturizing Vaginal Gel5 mL5001012022-04-12
00850014621940Almost Naked Hint of Mint1.69oz7003502023-07-05
00893268000987Almost Naked5ml2001032016-10-13
00850014621568Hybrid Lubricant1.69oz7002502022-05-09
00893268000239Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13
00893268000598Guilty Pleasure / Cinnamon Vanilla4oz.2003042016-10-13
00893268000031Guilty Pleasure / Cinnamon Vanilla5ml 2001062016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254647EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254654EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16