FDA.reportPublic FDA data

Optic Shop

Primary DI
20075063012509
Brand
Optic Shop
Company
PROOPTICS LLC
Model
125
Device description
Optic Shop Flip-Top Contact Lens Case
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K875197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875197000OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASEPro-Optics, Inc.1988-02-09LRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075063012512PackageGS150In Commercial Distribution
20075063012509PackageGS1144In Commercial Distribution
00075063012505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075063012512000750630125120750630125120075063012512
2007506301250920075063012509
00075063012505000750630125050750630125050075063012505

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
002977189
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087701431470Good Neighbor Pharmacy101906732024-09-13
00075063012505Optic Shop1252016-09-22
00725439991506Healthy Accents225-2HA2017-02-10
00725439991513Healthy Accents225-12HA2017-02-10
00075063122501Harmon Face Values225FV2016-12-09
00075063112502Harmon Face Values125FV2017-01-17
30075063122502Harmon Face Values225FV2016-12-09
00075063225127Optic Shop225-122017-05-05

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