FDA.reportPublic FDA data

Sea Striker

Primary DI
00083758612701
Brand
Sea Striker
Company
Cliff Weil, Inc.
Model
270
Catalog number
270
Device description
SEA STRIKER 270 POLARIZED SUNGLASSES
Published
2022-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
00083758612701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083758612701000837586127010837586127010083758612701

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

Regulatory Flags#

DUNS number
007941511
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083758000010Regency000100012022-10-27
00083758000065Regency000600062022-10-27
00083758000553Regency005500552022-10-27
00083758000560Regency005600452022-10-27
00083758000591Regency005900592022-10-27
00083758000652Regency006500652022-10-27
00083758001307Regency013001302022-10-27
00083758001376Regency013701372022-10-27
00083758002519Just A Shade Smaller3513512022-10-27
00083758002731Just A Shade Smaller3733732022-10-27
00083758002748Just A Shade Smaller3743742022-10-27
00083758002779Just A Shade Smaller3773772022-10-27
00083758006951Just A Shade SmallerJASS695JASS6952022-10-27
00083758009983Just A Shade SmallerJASS998JASS9982022-10-27
00083758010002RegencyREG1000REG10002022-10-27
00083758011986Just A Shade SmallerJASS1198JASS11982022-10-27
00083758012006RegencyREG1200REG12002022-10-27
00083758012990RegencyREG1299REG12992022-10-27
00083758014000RegencyREG1400REG14002022-10-27
00083758014994RegencyREG1499REG14992022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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