FDA.reportPublic FDA data

Blake Kuwahara

Primary DI
G131BK1013AB0S0
Brand
Blake Kuwahara
Company
Fade To Grey Corp.
Model
BK1013-Ant Brown-Sun
Device description
BK1013 Antique Brown-Sun - 47 * 21 - 145 CAT 2
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810110310971PrimaryGS10
G131BK1013AB0S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110310971008101103109718101103109710810110310971

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
000-000-0000gudid@blakekuwahara.com

Regulatory Flags#

DUNS number
080287087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810110314856Blake KuwaharaChambers-Pride2022-12-01
00810110314863Blake KuwaharaChambers-Pride-Sun2022-12-01
00810110314870Blake KuwaharaChambers-Blu Hrn2022-12-01
00810110314887Blake KuwaharaChambers-Blu Hrn-Sun2022-12-01
G131CHAMBERSPRD0Blake KuwaharaChambers-Pride2022-12-01
G131CHAMBERSPRD0S0Blake KuwaharaChambers-Pride-Sun2022-12-01
G131CHAMBERSBH0Blake KuwaharaChambers-Blu Hrn2022-12-01
G131CHAMBERSBH0S0Blake KuwaharaChambers-Blu Hrn-Sun2022-12-01
00810110314092Blake KuwaharaBK1018-Gold2022-11-01
00810110314108Blake KuwaharaBK1018-Gold-Sun2022-11-01
00810110314115Blake KuwaharaBK1018-Red2022-11-01
00810110314122Blake KuwaharaBK1018-Red-Sun2022-11-01
00810110314139Blake KuwaharaBK1018-Shiny Blk2022-11-01
00810110314146Blake KuwaharaBK1018-Shiny Blk-Sun2022-11-01
00810110314153Blake KuwaharaBK1018-White2022-11-01
00810110314160Blake KuwaharaBK1018-White-Sun2022-11-01
00810110314177Blake KuwaharaBK1019-Antq Pwtr2022-11-01
00810110314184Blake KuwaharaBK1019-Antq Pwtr-Sun2022-11-01
00810110314191Blake KuwaharaBK1019-Gold2022-11-01
00810110314207Blake KuwaharaBK1019-Gold-Sun2022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13