FDA.reportPublic FDA data

RETI-port/scan 21 delta plus²

Primary DI
04260157780293
Brand
RETI-port/scan 21 delta plus²
Company
Roland Consult Stasche & Finger GmbH
Model
29
Published
2023-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023525000RETISCAN, RETIPORTRoland Consult2004-03-26GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157780293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157780293042601577802934260157780293

GMDN Terms#

Term, Definition table
TermDefinition
ElectrooculographAn ophthalmic device used to record the gradual changes in the electric potential between the retina and the cornea during ocular motion in response to visual stimuli. This recorder is used with surface electrodes placed on the lateral canthi of each eye and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used to help diagnosis in certain forms of retinal diseases, e.g., assessing light and dark adaptation of the eye. It may have additional capability for recording the short, fast movements of the eyes made during reading and sleep.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314602160
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260157780200RETI-port/scan 21 basic202023-02-26
04260157780217RETI-port/scan 21 alpha212023-02-26
04260157780224RETI-port/scan 21 alpha plus222023-02-26
04260157780231RETI-port/scan 21 beta232023-02-26
04260157780248RETI-port/scan 21 beta plus242023-02-26
04260157780255RETI-port/scan 21 gamma252023-02-26
04260157780262RETI-port/scan 21 gamma plus262023-02-26
04260157780279RETI-port/scan 21 gamma plus²272023-02-26
04260157780286RETI-port/scan 21 delta plus282023-02-26

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Primary DI, Brand, Company table
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