FDA.reportPublic FDA data

Eagle Eyes

Primary DI
00810712014451
Brand
Eagle Eyes
Company
Eagle Eyes
Model
66000
Catalog number
66000
Device description
Magnifying DigiTec Glass 1.6x - Frame Material: Techlon™ PC- Rimless/160% Magnifying/ DigiTec® Non-Polarized Anti-Glare Glasses
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
HOISpectacle, Magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810712014451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810712014451008107120144518107120144510810712014451

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle-mounted magnifierA magnifying ophthalmic lens designed to be attached to a pair of spectacles and intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.

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
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