FDA.reportPublic FDA data

cleadew GP hydra one

Primary DI
04950055206512
Brand
cleadew GP hydra one
Company
OPHTECS CORPORATION
Model
60 mL
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251876000cleadew GP hydra oneOphtecs Corporation2025-10-09MRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04950055206512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04950055206512049500552065124950055206512

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose rigid contact lens solutionA sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
696350276
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04950055206505cleadew GP hydra one360 mL2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04950055206505cleadew 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
00364108422301LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
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