FDA.reportPublic FDA data

Native Visions

Primary DI
00812056033754
Brand
Native Visions
Company
ENCORE VISION, INC.
Model
Kokopelli
Device description
"Eyeglass Frame,""Kokopelli, Brown, 56-18-145"""
Published
2022-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812056033754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812056033754008120560337548120560337540812056033754

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154402791
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812056033396Native VisionsWolf2022-06-24
00812056033402Native VisionsWolf2022-06-24
00812056033419Timeless BeautyDaisy2022-06-24
00812056033426Timeless BeautyDaisy2022-06-24
00812056033433Timeless BeautyDaisy2022-06-24
00812056033440Timeless BeautyDaisy2022-06-24
00812056033457Timeless BeautyDestiny2022-06-24
00812056033464Timeless BeautyDivine2022-06-24
00812056033471Timeless BeautyDivine2022-06-24
00812056033488Timeless BeautyFantasy2022-06-24
00812056033495Timeless BeautyForget Me Not2022-06-24
00812056033501Timeless BeautyForget Me Not2022-06-24
00812056033518Timeless BeautyForget Me Not2022-06-24
00812056033525Timeless BeautyHarmony2022-06-24
00812056033532Timeless BeautyHarmony2022-06-24
00812056033549Timeless BeautyRose2022-06-24
00812056033556Timeless BeautyRose2022-06-24
00812056033563High Stakes EyewearHigh Roller2022-06-24
00812056033594Hispanic HeritageEl Sol2022-06-24
00812056033600Hispanic HeritageEl Sol2022-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04582669065522EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
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04582669065553EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10