FDA.reportPublic FDA data

Berkley

Primary DI
00028632713266
Brand
Berkley
Company
Pure Fishing, Inc.
Model
1362230
Device description
Sunglasses
Published
2022-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00028632713266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00028632713266000286327132660286327132660028632713266

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(803)451-3577gregory.tiller@purefishing.com

Regulatory Flags#

DUNS number
007272289
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00028632275764Berkley14540662022-07-21
00028632275795Berkley14540692022-07-21
20028632275768Berkley14540662022-07-21
10028632275792Berkley14540692022-07-21
00022021596188SpiderWire13109242022-07-20
00022021596256SpiderWire13109312022-07-20
00022021596263SpiderWire13109322022-07-20
00022021596270SpiderWire13109332022-07-20
00022021609222SpiderWire13582502022-07-20
00022021609277SpiderWire13582552022-07-20
00022021609307SpiderWire13582582022-07-20
00022021609635SpiderWire13623322022-07-20
00022021609659SpiderWire13623342022-07-20
00022021609666SpiderWire13623352022-07-20
00022021609680SpiderWire13623372022-07-20
00022021609734SpiderWire13627122022-07-20
00022021609741SpiderWire13627132022-07-20
00022021609758SpiderWire13627142022-07-20
00022021609765SpiderWire13627152022-07-20
00022021609772SpiderWire13627162022-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060265FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
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