FDA.report

Eagle Eyes

Primary DI
00810712010064
Brand
Eagle Eyes
Company
Eagle Eyes
Model
10013
Catalog number
10013
Device description
Extreme - Frame Material: Stainless Steel - Trilenium lens- Sunglasses
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810712010064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810712010064008107120100648107120100640810712010064

GMDN Terms

TermDefinition
Tinted spectacle lens, non-prescriptionAn ophthalmic device made of a treated glass or plastic that is used to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light, but not to provide refractive corrections. 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

Regulatory Flags

DUNS number
611195173
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810712010033Eagle Eyes10025100252020-08-31
00810712010057Eagle Eyes10019100192020-08-31
00810712010125Eagle Eyes15007150072020-08-31
00810712010132Eagle Eyes15008150082020-08-31
00810712010163Eagle Eyes20081200812020-08-31
00810712010231Eagle Eyes11001110012020-08-31
00810712010286Eagle Eyes10017100172020-08-31
00810712010293Eagle Eyes10027100272020-08-31
00810712010309Eagle Eyes10016100162020-08-31
00810712010316Eagle Eyes10028100282020-08-31
00810712010330Eagle Eyes10030100302020-08-31
00810712010347Eagle Eyes10015100152020-08-31
00810712010354Eagle Eyes20026200262020-08-31
00810712010385Eagle Eyes33060330602020-08-31
00810712010392Eagle Eyes20235202352020-08-31
00810712010408Eagle Eyes33235332352020-08-31
00810712010415Eagle Eyes40050400502020-08-31
00810712010439Eagle Eyes40013400132020-08-31
00810712010453Eagle Eyes40250402502020-08-31
00810712010460Eagle Eyes40016400162020-08-31

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