FDA.reportPublic FDA data

Menicon Progent Protein Remover

Primary DI
00853253003027
Brand
Menicon Progent Protein Remover
Company
MENICON AMERICA, INC.
Model
7P
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
MRCProducts, Contact Lens Care, Rigid Gas Permeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122273000MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.2013-01-02MRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853253003027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853253003027008532530030278532530030270853253003027

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens protein-removal solutionA formulation of proteolytic enzymes, that may or may not be dissolved in cleaning (and possibly disinfecting) contact lens solution, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. The lenses are typically soaked for a period in the solution and then rinsed in fresh contact lens cleaning solution for the removal of any residual material. Protein build-up on contact lenses often occurs from tear secretion. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034212507
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853253003003Menicon Unique pH Multi-Purpose Solution120mL2016-09-23
00853253003034Menicon Progent Protein Remover1P2016-09-23
00853253003058Menicon Unique pH Multi-Purpose SolutionStarter Kit2016-09-23
00853253003065Menicon Unique pH Multi-Purpose SolutionTravel Pack2016-09-23
00853253003195LacriPure98P2016-09-23
00853253003201LacriPure7P2016-09-23

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