EliteVue head only, XL, 2.5V 10511

GUDID 04045396209732

The Riester EliteVue was used to illuminate and examine the ear canal and eardrum in combination with the Riester ear funnels produced.

Rudolf Riester GmbH

Otoscope, direct

• Primary Device ID: 04045396209732
• NIH Device Record Key: 463e0fce-651b-49d0-9b9d-b2ee73efc29b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EliteVue head only, XL, 2.5V
• Version Model Number: 10511
• Catalog Number: 10511
• 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	04045396209732 [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

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