FDA.reportPublic FDA data

Eagle Eyes

Primary DI
00810712013409
Brand
Eagle Eyes
Company
Eagle Eyes
Model
12005SETLG
Catalog number
12005SETLG
Device description
GNM Freedom 55 Set Offer #1 w/ Binoculars(1) Freedom Flash GNM/SLV 55mm or 52mm - Polarized Sunglasses(1) Aviator NL - Night-Lite® Yellow Non-Polarized Glasses(1) Pair of Binocularsand accessories
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HJFMagnifier, Hand-Held, Low-Vision
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJFMagnifier, Hand-Held, Low-VisionOphthalmic1
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810712013409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810712013409008107120134098107120134090810712013409

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
611195173
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810712010033Eagle Eyes10025100252020-08-31
00810712010057Eagle Eyes10019100192020-08-31
00810712010064Eagle Eyes10013100132020-08-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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