uni® I otoscope XL 3.5 V, plug-in-style 2012-202

GUDID 04045396130135

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

Rudolf Riester GmbH

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• Primary Device ID: 04045396130135
• NIH Device Record Key: 952c96a8-8d7a-42c7-98fb-f70d8558b5a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uni® I otoscope XL 3.5 V, plug-in-style
• Version Model Number: 2012-202
• Catalog Number: 2012-202
• 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	04045396130135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925759

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

Devices Manufactured by Rudolf Riester GmbH

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