FDA.reportPublic FDA data

Optisource

Primary DI
00817096001497
Brand
Optisource
Company
PHOENIX HEALTHCARE SOLUTIONS, LLC
Model
74-0700-G
Device description
Sunglass-shaped Flatpack, Green 100/bag
Published
2024-08-18
Public version status
Update
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
K231123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231123000Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.2023-08-30LRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817096001497PrimaryGS10
10817096001494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817096001497008170960014978170960014970817096001497
1081709600149410817096001494

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079146847
Device count
100
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817096001404Optisource74-0323-A2024-08-18
00817096001411Optisource74-0323-B2024-08-18
00817096001428Optisource74-0323-C2024-08-18
00817096001435Optisource74-0323-G2024-08-18
00817096001442Optisource74-0323-O2024-08-18
00817096001459Optisource74-0323-W2024-08-18
00817096001466Optisource74-0700-A2024-08-18
00817096001473Optisource 74-0700-BK2024-08-18
00817096001480Optisource74-0700-BL2024-08-18
00817096001503Optisource74-0700-O2024-08-18
00817096001510Optisource74-0700-W2024-08-18
00817096001527Optisource74-1050-A2024-08-18
00817096001534Optisource74-1050-B2024-08-18
00817096001541Optisource74-1050-C2024-08-18
00817096001558Optisource74-1050-G2024-08-18
00817096001565Optisource74-1050-O2024-08-18
00817096001572Optisource74-1050-W2024-08-18
00360913027014Phoenix Healthcare Solutions LLC CL-012023-09-05
00360913028011Phoenix Healthcare Solutions LLC CL-022023-09-05
00360913029018Phoenix Healthcare Solutions LLC CL-032023-09-05

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
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
00360843008572OptegoOptego Vision USA Inc.LRX2023-08-23
00360843008589OptegoOptego Vision USA Inc.LRX2023-08-23
00360843008596OptegoOptego Vision USA Inc.LRX2023-08-23
00360843008602OptegoOptego Vision USA Inc.LRX2023-08-23