FDA.reportPublic FDA data

SpiderWire

Primary DI
10022021609687
Brand
SpiderWire
Company
Pure Fishing, Inc.
Model
1362337
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
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
10022021609687PackageGS13In Commercial Distribution
20022021609684PackageGS172In Commercial Distribution
00022021609680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002202160968710022021609687
2002202160968420022021609684
00022021609680000220216096800220216096800022021609680

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
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
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
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13