FDA.report

ZonedIn Contact Lenses

Primary DI
00810040143595
Brand
ZonedIn Contact Lenses
Company
ZONEDIN VISION, LLC
Model
SH1500BL
Catalog number
SH1500BL
Device description
Silicone hydrogel Daily wear soft contact lens trial +5.00 power (blisters)
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LPLLenses, soft contact, daily wear

Product Code Classifications

CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810040143595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040143595008100401435958100401435950810040143595

GMDN Terms

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

Regulatory Flags

DUNS number
117142079
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 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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