FDA.reportPublic FDA data

Equate

Primary DI
00078742019215
Brand
Equate
Company
WAL-MART STORES, INC.
Model
EQ16
Device description
Contact Lens Case, 6 Pack
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K130753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130753000STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASEWatchdog Group, LC2013-06-13LRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40078742019213PackageGS124Not in Commercial Distribution
00078742019215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4007874201921340078742019213
00078742019215000787420192150787420192150078742019215

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
Lot or batch
true

Other Devices From This Company#

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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