FDA.reportPublic FDA data

LensGiene

Primary DI
00364108422301
Brand
LensGiene
Company
OPTICS LABORATORY, INC.
Model
KSS02
Device description
Contact lens sterile saline solution
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRCProducts, Contact Lens Care, Rigid Gas Permeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00364108422301PrimaryGS10
00364108422011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00364108422301003641084223013641084223010364108422301
00364108422011003641084220113641084220110364108422011

GMDN Terms#

Term, Definition table
TermDefinition
Rigid contact lens cleaning solutionAn aqueous formulation containing appropriate agents for loosening debris from rigid gas permeable (RGP) or hard contact lenses, often with a gentle rubbing of the lenses. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
018503552
Device count
30
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00364108422011LensGieneKSS022023-05-05
00364108411121Eye-Cept Rewetting Drops4112016-06-07
00364108431242Eye-Cept Sterile Saline Solution4312016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04950055206505cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
04950055206512cleadew GP hydra oneOPHTECS CORPORATIONMRC2026-05-11
00095072096006Up&Up TARGET CORPORATIONMRC2026-04-22
00198168143803 Tangible Fill DRY EYE INNOVATIONS, LLCMRC2026-04-22
00850013056071VibrantVueDRY EYE INNOVATIONS, LLCMRC2025-12-01
00850013056095VibrantVue DRY EYE INNOVATIONS, LLCMRC2025-12-01
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedMRC2025-06-17
00713733766173MeijerMEIJER, INC.MRC2024-10-23
00713733766197MeijerMEIJER, INC.MRC2024-10-23
00198168596739Tangible Clean Sample BottleTANGIBLE SCIENCE, INC.MRC2024-04-22
00198168983577Tangible CleanTANGIBLE SCIENCE, INC.MRC2024-04-22
00860005853410Aqua Naina Sterile Saline Solution Chemtex USA Inc.MRC2024-03-20
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-10-25
00310119303696ScleralFilBausch & Lomb IncorporatedMRC2023-07-05
00364108422011LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
00310119022498Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-04-27
00850012123019NutrifillCONTAMAC SOLUTIONS, INC.MRC2022-08-04
00830002000018PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00830002000087PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00830002000094PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00681131176361EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179119EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179126EquateWAL-MART STORES, INC.MRC2020-11-17
00850012123002NutrifillCONTAMAC SOLUTIONS, INC.MRC2020-08-20
00310119303818up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2020-06-05
00310119054536Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054543Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054550Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00047113709338CLEAR CAREAlcon Laboratories, Inc.MRC2020-02-25
00858961791037up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2019-04-23