FDA.report

D-EYE

Primary DI
08053369320137
Brand
D-EYE
Company
D-EYE SRL
Model
DEI0300W1S1400
Device description
D-EYE for iPhone 6+/6S+
Published
2016-09-30
Public version status
Update
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
PJZCamera, Ophthalmic, General-Use

Product Code Classifications

CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08053369320137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08053369320137080533693201378053369320137

GMDN Terms

TermDefinition
Direct ophthalmoscopeAn electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a built-in light directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers.

Sterilization Methods

Method

Regulatory Flags

DUNS number
435711752
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
08053369320007D-EYEDEI0100W1S14002016-09-27
08053369320014D-EYEDEI0200W1S14002016-09-27
08053369320144D-EYEDEI0400W1S14002017-06-21

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