FDA.reportPublic FDA data

MeniconZ (tisilfocon A) Clear

Primary DI
00884465092011
Brand
MeniconZ (tisilfocon A) Clear
Company
MENICON CO.,LTD.
Model
Pale yellow
Published
2016-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily
MWLLens,Contact(Rigid Gas Permeable)-Extended Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2
MWLLens, Contact (Rigid Gas Permeable), Extended WearOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884465092011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884465092011008844650920118844650920110884465092011

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, extended-wearA 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); it is designed for continuous overnight wear for up to 7, 15, or 30 consecutive nights. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690680533
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884465091014MeniconZ (tisilfocon A) BlueBlue2016-06-20
00192538901086MeniconZ (tisilfocon A) RedWine Red2023-06-09
00192538951357ACUVUE Abiliti Overnight Therapeutic lenses for myopia managementACUVUE Abiliti2022-01-25
00192538951364ACUVUE Abiliti overnight for myopia management with astigmatismACUVUE Abiliti2022-01-25
00192538901079Menicon Progent Large Diameter Contact Lens CaseBC-790+2021-09-24
00192538901017Deluxe Scleral Lens KitMEN003212020-05-01
00192538901024Deluxe KitMEN003082020-05-01
00192538901031Basic Scleral Lens KitMEN003332020-05-01
00884465603064Miru 1day Menicon Flat Pack TC CP30+4.75/-1.75/1802017-08-31
00884465017106Miru 1day Menicon Flat Pack CP30+3.752017-02-28
00884465607291Miru 1day Menicon Flat Pack TC CP90-1.00/-0.75/1802017-08-31
00884465607307Miru 1day Menicon Flat Pack TC CP90-1.25/-0.75/1802017-08-31
00884465607314Miru 1day Menicon Flat Pack TC CP90-1.50/-0.75/1802017-08-31
00884465607321Miru 1day Menicon Flat Pack TC CP90-1.75/-0.75/1802017-08-31
00884465607338Miru 1day Menicon Flat Pack TC CP90-2.00/-0.75/1802017-08-31
00884465607345Miru 1day Menicon Flat Pack TC CP90-2.25/-0.75/1802017-08-31
00884465607352Miru 1day Menicon Flat Pack TC CP90-2.50/-0.75/1802017-08-31
00884465607369Miru 1day Menicon Flat Pack TC CP90-2.75/-0.75/1802017-08-31
00884465607376Miru 1day Menicon Flat Pack TC CP90-3.00/-0.75/1802017-08-31
00884465607383Miru 1day Menicon Flat Pack TC CP90-3.25/-0.75/1802017-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850085735024BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735048BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735055BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735062BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735079BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735086BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735109BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735123BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735130BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735147BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735154BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735161BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735178BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735185BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735192BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735208BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735215BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735239BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735253BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735260BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735277BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735284BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735291BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735314BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735338BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735345BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735352BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735369BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735376BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735383BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21