FDA.reportPublic FDA data

Native Visions

Primary DI
00812056033624
Brand
Native Visions
Company
ENCORE VISION, INC.
Model
Running Bear 2
Device description
"Eyeglass Frame,""Running Bear 2, Black/Red, 56-17-142"""
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
00812056033624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812056033624008120560336248120560336240812056033624

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
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033016FielmannFielmann Group AGHQZ2026-07-08
04066209033184FielmannFielmann Group AGHQZ2026-07-08
04066209040083FielmannFielmann Group AGHQZ2026-07-08
04066209044883FielmannFielmann Group AGHQZ2026-07-08
04066209046917FielmannFielmann Group AGHQZ2026-07-08
04066209046924FielmannFielmann Group AGHQZ2026-07-08
04066209047051FielmannFielmann Group AGHQZ2026-07-08
04066209049178FielmannFielmann Group AGHQZ2026-07-08
04066209051140FielmannFielmann Group AGHQZ2026-07-08
04066209051201FielmannFielmann Group AGHQZ2026-07-08
04066209052475FielmannFielmann Group AGHQZ2026-07-08
04066209052673FielmannFielmann Group AGHQZ2026-07-08
04066209052697FielmannFielmann Group AGHQZ2026-07-08
04066209052932FielmannFielmann Group AGHQZ2026-07-08
04066209055445FielmannFielmann Group AGHQZ2026-07-08
04066209055803FielmannFielmann Group AGHQZ2026-07-08
04066209056213FielmannFielmann Group AGHQZ2026-07-08
04066209058637FielmannFielmann Group AGHQZ2026-07-08
04066209058644FielmannFielmann Group AGHQZ2026-07-08
04066209058934FielmannFielmann Group AGHQZ2026-07-08
04066209059795FielmannFielmann Group AGHQZ2026-07-08
04066209060074FielmannFielmann Group AGHQZ2026-07-08
04066209060081FielmannFielmann Group AGHQZ2026-07-08
04066209060425FielmannFielmann Group AGHQZ2026-07-08
04066209060487FielmannFielmann Group AGHQZ2026-07-08
04066209060517FielmannFielmann Group AGHQZ2026-07-08
04066209063525FielmannFielmann Group AGHQZ2026-07-08
04066209063600FielmannFielmann Group AGHQZ2026-07-08
03701629014160Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07