FDA.reportPublic FDA data

Sun Designe

Primary DI
00860008278883
Brand
Sun Designe
Company
John A Taber
Model
83
Device description
Uncut Rx Optical Frame Lenses
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
HQGLens, Spectacle, Non-Custom (Prescription)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQGLens, Spectacle, Non-Custom (Prescription)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008278883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008278883008600082788838600082788830860008278883

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectacle lens, non-customizedAn ophthalmic lens made of glass or plastic that is manufactured in accordance with a standard prescription (not customized for a specific patient) and intended to be worn in front of the eyes to correct the refractive errors of a patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.

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
00860008278814Sun Designe 142022-03-09
00860008278821Sun Designe212022-03-09
00860008278845Sun Designe452022-03-09
00860008278852Sun Designe522022-03-09
00860008278876Sun Designe762022-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054917321697Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321703Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321840Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321857Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339777Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339791Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340247Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340261Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340278Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340292Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340308Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345914Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345938Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345945Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917347673Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821163Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821170Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821187Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821194Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821200Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821217Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821224Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821231Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821248Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821255Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821262Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821279Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821286Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821293Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478825475Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25