FDA.reportPublic FDA data

Berkley

Primary DI
20028632275768
Brand
Berkley
Company
Pure Fishing, Inc.
Model
1454066
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
10028632275761PackageGS13In Commercial Distribution
20028632275768PackageGS172In Commercial Distribution
00028632275764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002863227576110028632275761
2002863227576820028632275768
00028632275764000286322757640286322757640028632275764

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
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
00022021612079SpiderWire13637062022-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973541157797SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158227SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158234SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158241SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158258SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158265SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158272SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158289SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158296SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158302SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228670Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14