RETI-port/scan 21 delta plus

GUDID 04260157780286

Roland Consult Stasche & Finger GmbH

Electroretinograph

• Primary Device ID: 04260157780286
• NIH Device Record Key: 3185895b-a19f-49d7-91cb-6381fa2f0416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETI-port/scan 21 delta plus
• Version Model Number: 28
• Company DUNS: 314602160
• Company Name: Roland Consult Stasche & Finger GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260157780286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023525

FDA Product Code

• GWE: Stimulator, Photic, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-06
• Device Publish Date: 2023-02-26

Devices Manufactured by Roland Consult Stasche & Finger GmbH

• 04260157780200 - RETI-port/scan 21 basic: 2023-03-06
• 04260157780217 - RETI-port/scan 21 alpha: 2023-03-06
• 04260157780224 - RETI-port/scan 21 alpha plus: 2023-03-06
• 04260157780231 - RETI-port/scan 21 beta: 2023-03-06
• 04260157780248 - RETI-port/scan 21 beta plus: 2023-03-06
• 04260157780255 - RETI-port/scan 21 gamma: 2023-03-06
• 04260157780262 - RETI-port/scan 21 gamma plus: 2023-03-06
• 04260157780279 - RETI-port/scan 21 gamma plus²: 2023-03-06