FDA.report

FIN-NOR

Primary DI
00029959945002
Brand
FIN-NOR
Company
Pure Fishing, Inc.
Model
1576305
Catalog number
TIL 024 00CG
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
00029959945002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00029959945002000299599450020299599450020029959945002

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(386)569-1834fletcher.robins@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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20022021609776SpiderWire13627162022-07-20
10022021612076SpiderWire13637062022-07-20
10022021613004SpiderWire13642212022-07-20

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