FDA.reportPublic FDA data

Eye-Cept Sterile Saline Solution

Primary DI
00364108431242
Brand
Eye-Cept Sterile Saline Solution
Company
OPTICS LABORATORY, INC.
Model
431
Device description
10ml single use sterile saline solution for soft contact lens
Published
2016-07-22
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
LPNAccessories, Soft Lens Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110221000EYE-CEPT STERILE SALINE SOLUTIONOptics Laboratory, Inc.2011-11-01LPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00364108431242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00364108431242003641084312423641084312420364108431242

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens rinsing solutionA sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
018503552
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00364108422301LensGieneKSS022023-05-05
00364108422011LensGieneKSS022023-05-05
00364108411121Eye-Cept Rewetting Drops4112016-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00310119041062Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041086Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041420Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041468Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044230Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044247Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119304242up & up multipurpose solutionTARGET CORPORATIONLPN2026-01-09
00780707000007HydravueUnited Exchange Corp.LPN2025-05-23
00310119030189renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119030486renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031186renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031223renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119032220renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00194346415397EquateWAL-MART STORES, INC.LPN2024-12-05
00310119041307Target saline solution sensitive eyesTARGET CORPORATIONLPN2024-07-16
00310119304495up & up multipurpose solutionTARGET CORPORATIONLPN2024-07-16
00606492119079HydroPureOte North America LLCLPN2024-07-15
00606492119086HydroPureOte North America LLCLPN2024-07-10
00310119304501WalgreensWALGREEN CO.LPN2024-06-21
05060503857803Chromaview Multi-Purpose SolutionARCADANT B.V.LPN2024-05-22
00351801021016Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00351801021030Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00197644026180Clear ConscienceClear ConscienceLPN2024-03-21
00197644945504Clear Conscience Clear ConscienceLPN2024-03-21
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedLPN2023-10-25
00827444001512REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001529REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001536REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001550REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
30827444001513REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09