FDA.report

FINTECH

Primary DI
00841543149166
Brand
FINTECH
Company
Inspecs U.S.A., L.C.
Model
FTS-GREAT WHITE-100P
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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841543149166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841543149166008415431491668415431491660841543149166

GMDN Terms

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

Regulatory Flags

DUNS number
845937478
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
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 DIBrandCompanyProduct codePublished
06973541158162SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158179SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158186SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158193SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158209SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158216SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158223SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158230SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158247SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158254SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158261SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158278SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158285SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158292SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158308SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
08800332269531Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269548Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269586Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269593Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269616Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269623Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269630Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269647Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269654Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269661Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269678Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269685Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269692Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269708Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269715Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22