ri-scope® L Oto- L3 /Ophthal. L2, LED/XL 3,5 V, 3746-550

GUDID 04045396148758

The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground.

Rudolf Riester GmbH

Ophthalmic/otologic diagnostic set

• Primary Device ID: 04045396148758
• NIH Device Record Key: 12a0b2b0-6ae5-4a4b-80b6-1c588ad878cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-scope® L Oto- L3 /Ophthal. L2, LED/XL 3,5 V,
• Version Model Number: 3746-550
• Catalog Number: 3746-550
• 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	04045396148758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932506

FDA Product Code

• ERA: Otoscope

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

On-Brand Devices [ri-scope® L Oto- L3 /Ophthal. L2, LED/XL 3,5 V,]

• 04045396153677: The Riester otoscope is produced for illumination and examination of the auditory canal in combi
• 04045396148758: The Riester otoscope is produced for illumination and examination of the auditory canal in combi