RETI-port/scan 21 gamma plus²

Basic Information

• Brand Name: RETI-port/scan 21 gamma plus²
• Primary DI: 04260157780279
• Version / Model: 27
• Company Name: Roland Consult Stasche & Finger GmbH
• Labeler DUNS: 314602160
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-26
• Public Version: 1
• Public Version Date: 2023-03-06
• Public Version Status: New
• Public Device Record Key: 0d0fb5f2-2ab5-4254-a780-2852ed98bf1c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWE	Stimulator, Photic, Evoked Response	Neurology	882.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11482	Electroretinograph	An 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.	No	Active
11480	Electrooculograph	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260157780279	GS1

Premarket Submissions

Submission Number	Supplement Number
K023525	000