FDA.reportPublic FDA data

MeniconZ (tisilfocon A) Red

Primary DI
00192538901086
Brand
MeniconZ (tisilfocon A) Red
Company
MENICON CO.,LTD.
Model
Wine Red
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWLLens, Contact (Rigid Gas Permeable), Extended Wear
NUULens, Contact, Orthokeratology, Overnight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWLLens, Contact (Rigid Gas Permeable), Extended WearOphthalmic3
NUULens, Contact, Orthokeratology, OvernightOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192538901086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192538901086001925389010861925389010860192538901086

GMDN Terms#

Term, Definition table
TermDefinition
Orthokeratology contact lensA rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. 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. This 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
00884465092011MeniconZ (tisilfocon A) ClearPale yellow2016-06-20
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
00850007135515Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135522Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135539Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135546Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000183Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000190Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000206Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000213Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000244Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000251Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000268Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000275Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000282Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000299Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000305Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000312Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000329Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000336Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000343Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000350Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099965Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099972Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099989Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099996Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135604Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135611Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501468Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501475Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501512Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501529Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05