FDA.reportPublic FDA data

S4 OPTIK

Primary DI
08056098470319
Brand
S4 OPTIK
Company
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Model
COBRA
Catalog number
103303A00 V0/S10
Device description
COBRA FUNDUS CAMERA
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFJSystem, Image Management, OphthalmicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132987000COBRA FUNDUS CAMERAC.S.O. S.R.L.2014-07-03HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056098470319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056098470319080560984703198056098470319

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Regulatory Flags#

DUNS number
432448470
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056098470012LUMENISSL 990 3X LUMENIS100226A302016-08-03
08056098470029ALCONSLIT LAMP SL 1000100209A502016-08-03
08056098470036LUMENISSL 990 5X LUMENIS100226A502016-09-30
08056098470043LUMENISSL 990 5X/Z LUMENIS100239A502016-09-30
08056098470128S4 OPTIKSL 9900 3X DIGITAL100257A30.D V02016-09-30
08056098470135S4 OPTIKSL 9900 3X 100257A30.J V02016-09-13
08056098470210S4 OPTIKSL 9800 3X LED + FILTER100258A30.J V02016-09-30
08056098470227S4 OPTIKSL 9800 5X LED DIGITAL100258A50.D V02016-09-30
08056098470258S4 OPTIKSL 990 5X ELITE100258A50.D V02016-09-30
08056098470265IRIDEXSL 9900 5X 100270A50.E V12016-09-30
08056098470272IRIDEXSL 9800 5X 1002072A50.E V12016-09-30
08056098470647S4 OPTIKSL 990 5X 100250A50.J V02016-09-13
08056098470654IRIDEXSL 980 5X 100213A50.E V12016-09-30
08056098470159S4 OPTIKSL 990 5X LED digital100257A50.D V02020-12-10
08056098470166S4 OPTIKSL 990 25X LED 100257A50.R V02020-12-10
08056098470197S4 OPTIKSL 9800 2X LED 100258A20.R V02020-12-10
08056098470234S4 OPTIKSL 9800 5X LED 100258A50.J V02020-12-10
08056098470678S4 OPTIKSL 9800 zoom100258AZ0.J V02020-12-10
08056098470708S4 OPTIKSL 990 2X LED 100257A20.R V02020-12-10
08056098470753S4 OPTIKSL 9800 2X100272A20.R V02020-12-10

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