PMMA

Primary DI
00858174006003
Brand
PMMA
Company
LAGADO CORPORATION, THE
Model
003
Device description
PMMA (polymethyl methacrylate) hard contact lens for daily wear
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HPXLens, Contact (Polymethylmethacrylate)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPXLens, Contact (Polymethylmethacrylate)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895411000OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.1990-02-27HPX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858174006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858174006003008581740060038581740060030858174006003

GMDN Terms#

Term, Definition table
TermDefinition
Hard corrective contact lensA rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia). The device is made of polymethylmethacrylate (PMMA), also known as Plexiglas or Lucite, and does not permit diffusion of oxygen (O2) to the ocular surface. These lenses are virtually obsolete and rarely used. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
109884150
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858174006010SA-180102016-08-05
00858174006027SA-320272016-08-05
00858174006034FLOSI0342016-08-04
00858174006041ONSI-560412016-08-04
00858174006058TYRO-970582016-08-04
00858174006522OP-25222016-08-05
00858174006539OP-35392016-08-05
00858174006560OP-65602016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B22202Paraperm O2Paragon Vision Sciences, Inc.HPX2018-02-23