FDA.reportPublic FDA data

Optego

Primary DI
00360843008572
Brand
Optego
Company
Optego Vision USA Inc.
Model
93844-SF
Device description
Contact Lens Cases, Assorted Colors, 12/pk
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRXCase, Contact Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRXCase, Contact LensOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112832000EYE CARE CURE CONTACT LENS CASEEye Care and Cure2011-12-05LRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00360843008572PrimaryGS10
00360843008961Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00360843008572003608430085723608430085720360843008572
00360843008961003608430089613608430089610360843008961

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens caseA container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.

Regulatory Flags#

DUNS number
835541145
Device count
12
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00360843006523Optego978369-Optego2023-11-10
00360843006530Optego978369-Optego2023-11-10
00360843009395Optego978362023-11-10
00360843010964Optego98343062024-07-24
00360843010971Optego9827032024-07-24
00360843009142Optego983432024-02-01
00360843009340Optego982702024-01-12
00360843006912Optego9835602024-02-01
00360843006929Optego9835612024-02-01
00360843007247Optego982752024-02-01
00360843009135Optego983392024-02-01
00360843010698Optego983152024-02-01
00360843009364Optego982732024-01-12
00360843007940Optego942882024-01-11
00360843007957Optego942892024-01-11
00360843007964Optego942902024-01-11
00360843007971Optego942912024-01-11
00360843007988Optego942922024-01-11
00360843007995Optego942932024-01-11
00360843008008Optego942942024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00078041249498Up & UpTARGET CORPORATIONLRX2025-12-19
00087701431470Good Neighbor PharmacyPROOPTICS LLCLRX2024-09-13
00817096001404OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001411OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001428OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001435OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001442OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001459OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001466OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001473Optisource PHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001480OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001497OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001503OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001510OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001527OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001534OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001541OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001558OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001565OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00817096001572OptisourcePHOENIX HEALTHCARE SOLUTIONS, LLCLRX2024-08-18
00011822318068RITE AIDSACKS HOLDINGS, INC.LRX2024-03-28
00635515966918QUALITY CHOICESACKS HOLDINGS, INC.LRX2024-03-28
06976832583728EquateWAL-MART STORES, INC.LRX2023-11-27
06976832583735EquateWAL-MART STORES, INC.LRX2023-11-27
00360913027014Phoenix Healthcare Solutions LLC PHOENIX HEALTHCARE SOLUTIONS, LLCLRX2023-09-05
00360913028011Phoenix Healthcare Solutions LLC PHOENIX HEALTHCARE SOLUTIONS, LLCLRX2023-09-05
00360913029018Phoenix Healthcare Solutions LLC PHOENIX HEALTHCARE SOLUTIONS, LLCLRX2023-09-05
00360843008589OptegoOptego Vision USA Inc.LRX2023-08-23
00360843008596OptegoOptego Vision USA Inc.LRX2023-08-23
00360843008602OptegoOptego Vision USA Inc.LRX2023-08-23