FDA.reportPublic FDA data

RETI-port/scan 21 basic

Primary DI
04260157780200
Brand
RETI-port/scan 21 basic
Company
Roland Consult Stasche & Finger GmbH
Model
20
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
04260157780200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157780200042601577802004260157780200

GMDN Terms#

Term, Definition table
TermDefinition
ElectroretinographAn ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.

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
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
04260157780293RETI-port/scan 21 delta plus²292023-02-26

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