RETI-port/scan 21 delta plus²

GUDID 04260157780293

Roland Consult Stasche & Finger GmbH

Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph Electrooculograph
Primary Device ID04260157780293
NIH Device Record Key6509ba9b-beb3-423d-9c81-8646e20fd6b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETI-port/scan 21 delta plus²
Version Model Number29
Company DUNS314602160
Company NameRoland Consult Stasche & Finger GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157780293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWEStimulator, Photic, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-06
Device Publish Date2023-02-26

Devices Manufactured by Roland Consult Stasche & Finger GmbH

04260157780200 - RETI-port/scan 21 basic2023-03-06
04260157780217 - RETI-port/scan 21 alpha2023-03-06
04260157780224 - RETI-port/scan 21 alpha plus2023-03-06
04260157780231 - RETI-port/scan 21 beta2023-03-06
04260157780248 - RETI-port/scan 21 beta plus2023-03-06
04260157780255 - RETI-port/scan 21 gamma2023-03-06
04260157780262 - RETI-port/scan 21 gamma plus2023-03-06
04260157780279 - RETI-port/scan 21 gamma plus²2023-03-06

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