FDA.report

Blake Kuwahara

Primary DI
G131LANDISIS0S0
Brand
Blake Kuwahara
Company
Fade To Grey Corp.
Model
Landis-IndgoStrp-Sun
Device description
LANDIS Indigo Stripe-Sun - 46 * 23 - 140 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

Related Records

Contact Domains

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810110312616PrimaryGS10
G131LANDISIS0S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110312616008101103126168101103126160810110312616

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
G131CHAMBERSPRD0Blake KuwaharaChambers-Pride2022-12-01
G131CHAMBERSPRD0S0Blake KuwaharaChambers-Pride-Sun2022-12-01
G131CHAMBERSBH0Blake KuwaharaChambers-Blu Hrn2022-12-01
G131CHAMBERSBH0S0Blake KuwaharaChambers-Blu Hrn-Sun2022-12-01
G131ALSOPBK0S0Blake KuwaharaAlsop-Bark-Sun2022-09-01
G131ALSOPMD0S0Blake KuwaharaAlsop-Midnight-Sun2022-09-01
G131ALSOPPWT0S0Blake KuwaharaAlsop-Pewter-Sun2022-09-01
G131BIGGERBLOREBNH0S0Blake KuwaharaBigr Blore-BrnHrn-Sn2022-09-01
G131BIGGERBLOREGF0S0Blake KuwaharaBigr Blore-Gry Fd-Sn2022-09-01
G131BIGGERBLOREMD0S0Blake KuwaharaBigr Blore-Midnt-Sun2022-09-01
G131BIGGERBLORESH0S0Blake KuwaharaBigr Blore-SltHrn-Sn2022-09-01
G131BK1004BH0S0Blake KuwaharaBK1004-Blk Horn-Sun2022-09-01
G131BK1004BLH0S0Blake KuwaharaBK1004-Blue Hrn-Sun2022-09-01
G131BK1004CEHH0S0Blake KuwaharaBK1004-Cdr Horn-Sun2022-09-01
G131BK1004GH0S0Blake KuwaharaBK1004-Gry Horn-Sun2022-09-01
G131BK1005BL0S0Blake KuwaharaBK1005-Black-Sun2022-09-01
G131BK1005TR0S0Blake KuwaharaBK1005-Tortoise-Sun2022-09-01
G131BK1005WH0S0Blake KuwaharaBK1005-White-Sun2022-09-01
G131BK1006AB0S0Blake KuwaharaBK1006-Antq Brwn-Sun2022-09-01
G131BK1006GL0S0Blake KuwaharaBK1006-Gold-Sun2022-09-01

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