FDA.reportPublic FDA data

Miru 1day Menicon Flat Pack TC CP30

Primary DI
00884465602302
Brand
Miru 1day Menicon Flat Pack TC CP30
Company
MENICON CO.,LTD.
Model
-1.25/-1.25/180
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884465602302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884465602302008844656023028844656023020884465602302

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-disposableA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690680533
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884465091014MeniconZ (tisilfocon A) BlueBlue2016-06-20
00884465092011MeniconZ (tisilfocon A) ClearPale yellow2016-06-20
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

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Primary DI, Brand, Company table
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