uni® II May-ophthalmoscope XL 2.5 V 2020

GUDID 04045396002746

The Riester ophthalmoscope has been designed for the examination of the eye and its background.

Rudolf Riester GmbH

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• Primary Device ID: 04045396002746
• NIH Device Record Key: adc9e48e-5d40-45b4-a8e8-050d7c158138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uni® II May-ophthalmoscope XL 2.5 V
• Version Model Number: 2020
• Catalog Number: 2020
• Company DUNS: 537208717
• Company Name: Rudolf Riester 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: true
• Serial Number: false
• 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	04045396002746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925756

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

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: 2021-02-05
• Device Publish Date: 2021-01-28

Devices Manufactured by Rudolf Riester GmbH

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