FDA.reportPublic FDA data

FINTECH

Primary DI
00841543149241
Brand
FINTECH
Company
Inspecs U.S.A., L.C.
Model
FTS-THRESHER-104P
Device description
SUNGLASS
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00841543149241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841543149241008415431492418415431492410841543149241

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
845937478
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00832886306750CATERPILLARCTS-HOOK-1082022-12-01
00841543112597SUPERDRYSDS-SAN-1062022-12-01
00841543117219SUPERDRYSDS-SAN-1082022-12-01
00841543117295CARLOS SANTANACSS-AMARA-104P2022-12-01
00841543117301CARLOS SANTANACSS-AMARA-107P2022-12-01
00841543117318CARLOS SANTANACSS-AMARA-160P2022-12-01
00841543117325CARLOS SANTANACSS-DELIA-101P2022-12-01
00841543117332CARLOS SANTANACSS-DELIA-104P2022-12-01
00841543117349CARLOS SANTANACSS-DELIA-162P2022-12-01
00841543117356CARLOS SANTANACSS-BRIANNE-104P2022-12-01
00841543117363CARLOS SANTANACSS-BRIANNE-107P2022-12-01
00841543117370CARLOS SANTANACSS-BRIANNE-162P2022-12-01
00841543117585CARLOS SANTANASTS-NOBLE-106P2022-12-01
00841543117639CARLOS SANTANASTS-LION-102P2022-12-01
00841543117653CARLOS SANTANASTS-HAWKINS-101P2022-12-01
00841543117660CARLOS SANTANASTS-HAWKINS-102P2022-12-01
00841543117677CARLOS SANTANASTS-HAWKINS-104P2022-12-01
00841543117684CARLOS SANTANASTS-VUKU-102P2022-12-01
00841543117691CARLOS SANTANASTS-VUKU-104P2022-12-01
00841543117707CARLOS SANTANASTS-VUKU-127P2022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08054342061061Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342061849Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061856Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061863Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061870Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061887Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061894Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061900Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061917Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061924Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061931Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061948Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061955Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061962Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061979Mad in Italy MAD IN ITALY SRLHQY2026-04-13