FDA.report

read on

Primary DI
07640288790472
Brand
read on
Company
Read On Inc.
Model
7640288790472
Device description
"3 mm eyewear & hard case, red, +1.0 dpt, 1 unit in paper box incl. leaflet "
Published
2023-12-05
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

Product Codes

CodeName
HOISpectacle, Magnifying

Product Code Classifications

CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640288790472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640288790472076402887904727640288790472

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118891606
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07640288791059read on76402887906182023-12-08
07640288791066read on76402887906252023-12-08
07640288790359read on76402887903592023-12-05
07640288790366read on76402887903662023-12-05
07640288790373read on76402887903732023-12-05
07640288790380read on76402887903802023-12-05
07640288790397read on76402887903972023-12-05
07640288790403read on76402887904032023-12-05
07640288790410read on76402887904102023-12-05
07640288790427read on76402887904272023-12-05
07640288790434read on76402887904342023-12-05
07640288790441read on76402887904412023-12-05
07640288790458read on76402887904582023-12-05
07640288790465read on76402887904652023-12-05
07640288790489read on76402887904892023-12-05
07640288790496read on76402887904962023-12-05
07640288790502read on76402887905022023-12-05
07640288790519read on76402887905192023-12-05
07640288790526read on76402887905262023-12-05
07640288790533read on76402887905332023-12-05

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