AccessGUDID - DEVICE: RETI-port/scan 21 beta (04260157780231)

GUDID

Device Identifier (DI) Information

Brand Name: RETI-port/scan 21 beta
Version or Model: 23
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Roland Consult Stasche & Finger GmbH

Primary DI Number: 04260157780231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314602160 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWE	Stimulator, Photic, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04c4548b-2899-43bd-8b4f-049ad3c2df9c
Public Version Date: March 06, 2023
Public Version Number: 1
DI Record Publish Date: February 26, 2023