FDA.reportPublic FDA data

Berkley

Primary DI
10028632275792
Brand
Berkley
Company
Pure Fishing, Inc.
Model
1454069
Device description
Sunglasses
Published
2022-07-21
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

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
10028632275792PackageGS13In Commercial Distribution
20028632275799PackageGS172In Commercial Distribution
00028632275795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002863227579210028632275792
2002863227579920028632275799
00028632275795000286322757950286322757950028632275795

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
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00028632275764Berkley14540662022-07-21
00028632275795Berkley14540692022-07-21
20028632275768Berkley14540662022-07-21
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
00022021612079SpiderWire13637062022-07-20

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
08800348920280Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920297Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920303Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920310Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920327Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920334Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920341Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920358Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920365Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920372Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25