FDA.report

Shakespeare

Primary DI
10043388320664
Brand
Shakespeare
Company
Pure Fishing, Inc.
Model
1362093
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

Related Records

Contact Domains

Product Codes

CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10043388320664PackageGS13In Commercial Distribution
20043388320661PackageGS172In Commercial Distribution
00043388320667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004338832066410043388320664
2004338832066120043388320661
00043388320667000433883206670433883206670043388320667

GMDN Terms

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

Contacts

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

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10022021609274SpiderWire13582552022-07-20
10022021609304SpiderWire13582582022-07-20
10022021609632SpiderWire13623322022-07-20
10022021609656SpiderWire13623342022-07-20
10022021609663SpiderWire13623352022-07-20
10022021609687SpiderWire13623372022-07-20
20022021609738SpiderWire13627122022-07-20
10022021609748SpiderWire13627132022-07-20
10022021609755SpiderWire13627142022-07-20
10022021609762SpiderWire13627152022-07-20
20022021609776SpiderWire13627162022-07-20
10022021612076SpiderWire13637062022-07-20
10022021613004SpiderWire13642212022-07-20

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