FDA.reportPublic FDA data

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Primary DI
07640288790281
Brand
read on
Company
Solsolito GmbH
Model
7640288790281
Device description
4 mm eyewear, black, +2.0 dpt, not packaged
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07640288790304PackageGS12In Commercial Distribution
07640288790281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640288790304076402887903047640288790304
07640288790281076402887902817640288790281

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Regulatory Flags#

DUNS number
486286490
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640288790106read on76402887901062022-12-16
07640288790113read on76402887901132022-12-16
07640288790137read on76402887901372022-12-16
07640288790144read on76402887901442022-12-16
07640288790168read on76402887901682022-12-12
07640288790175read on76402887901752022-12-16
07640288790199read on76402887901992022-12-16
07640288790205read on76402887902052022-12-16
07640288790229read on76402887902292022-12-16
07640288790236read on76402887902362022-12-16
07640288790250read on76402887902502022-12-16
07640288790267read on76402887902672022-12-16
07640288790298read on76402887902982022-12-16
07640288790311read on76402887903112022-12-16
07640288790328read on76402887903282022-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00628120772821AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772838AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772852AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772869AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772890AYA OpticalClaudia Alan IncHOI2025-01-18
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00628120773835AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773842AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773859AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773873AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773880AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773903AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773910AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
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