FDA.reportPublic FDA data

ZonedIn Contact Lenses

Primary DI
00810040144295
Brand
ZonedIn Contact Lenses
Company
ZONEDIN VISION, LLC
Model
SH1175BO
Catalog number
SH1175BO
Device description
Silicone hydrogel Daily wear soft contact lens power +1.75 (boxes)
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPLLenses, soft contact, daily wear
MVNLens, contact, (disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2
MVNLens, Contact, (Disposable)Ophthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040144295PrimaryGS10
00810040144110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040144295008100401442958100401442950810040144295
00810040144110008100401441108100401441100810040144110

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.

Regulatory Flags#

DUNS number
117142079
Device count
6
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040146244ZonedIn Vision Contact Lenses0010012021-01-22
00810040146251ZonedIn Vision Contact Lenses0020022021-01-22
00810040146268ZonedIn Vision Contact Lenses0030032021-01-22
00810040146275ZonedIn Vision Contact Lenses0040042021-01-22
00810040146282ZonedIn Vision Contact Lenses0050052021-01-22
00810040146299ZonedIn Vision Contact Lenses0060062021-01-22
00810040146305ZonedIn Vision Contact Lenses0070072021-01-22
00810040146312ZonedIn Vision Contact Lenses0080082021-01-22
00810040146329ZonedIn Vision Contact Lenses0090092021-01-22
00810040146336ZonedIn Vision Contact Lenses0100102021-01-22
00810040146343ZonedIn Vision Contact Lenses0110112021-01-22
00810040146350ZonedIn Vision Contact Lenses0120122021-01-22
00810040146367ZonedIn Vision Contact Lenses0130132021-01-22
00810040146374ZonedIn Vision Contact Lenses0140142021-01-22
00810040146381ZonedIn Vision Contact Lenses0150152021-01-22
00810040146398ZonedIn Vision Contact Lenses0160162021-01-22
00810040146404ZonedIn Vision Contact Lenses0170172021-01-22
00810040146411ZonedIn Vision Contact Lenses0180182021-01-22
00810040146428ZonedIn Vision Contact Lenses0190192021-01-22
00810040146435ZonedIn Vision Contact Lenses0200202021-01-22

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