FDA.reportPublic FDA data

Sun Designe

Primary DI
00860008278814
Brand
Sun Designe
Company
John A Taber
Model
14
Device description
Metal Rx Spectacle Frame
Published
2022-03-09
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
00860008278814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008278814008600082788148600082788140860008278814

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
134097091
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008278807Sun Designe072022-03-09
00860008278821Sun Designe212022-03-09
00860008278845Sun Designe452022-03-09
00860008278852Sun Designe522022-03-09
00860008278876Sun Designe762022-03-09
00860008278883Sun Designe832022-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08447504028307ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028345ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028383ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028420ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029342ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029380ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029427ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029465ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031529ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031567ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031604ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031642ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032007ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032045ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032083ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032120ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032168ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032205ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032243ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032281ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035251ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036777ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036814ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036852ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036890ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037897ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037934ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26