ri-scope® F.O. nasal speculum LED 3.5 V, 10575-301

GUDID 04045396147157

The nasal speculum is produced for illumination and therefore examination of the inside of the nose.

Rudolf Riester GmbH

ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set ENT diagnostic set

• Primary Device ID: 04045396147157
• NIH Device Record Key: a501b743-6b02-4d5c-8c31-9320b354349a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-scope® F.O. nasal speculum LED 3.5 V,
• Version Model Number: 10575-301
• Catalog Number: 10575-301
• 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	04045396147157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950913

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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