FDA.reportPublic FDA data

EQUATE

Primary DI
10681131248935
Brand
EQUATE
Company
WAL-MART STORES, INC.
Model
SC-206
Device description
CONTACT LENS CASE, 1 PACK
Published
2018-10-02
Public version status
New
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
K991206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991206000BONASSE CONTACT LENS CASEBonasse Ent. Co., Ltd.2000-06-06LRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10681131248935PackageGS11In Commercial Distribution
00681131248938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068113124893510681131248935
00681131248938006811312489386811312489380681131248938

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
051957769
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
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00194346693139EquateWAL4245V4WAL4245V42026-06-02
00681131106108Equate5998092362026-02-25
00681131106092Equate5997602702026-02-25
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00194346404155EquateEM472026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28
00194346699421EquateFBL7100072026-04-17
00194346219230ReliOn™ Premier Classic Meter784001N/A2025-02-11

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
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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