ri-scope® L2 F.O. otoscope head XL 2.5 V 10564

GUDID 04045396141223

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

Rudolf Riester GmbH

Otoscope, direct

• Primary Device ID: 04045396141223
• NIH Device Record Key: fc0300bc-1d58-4a60-872f-8b2edff42d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-scope® L2 F.O. otoscope head XL 2.5 V
• Version Model Number: 10564
• Catalog Number: 10564
• 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	04045396141223 [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

Devices Manufactured by Rudolf Riester GmbH

• 04045396007017 - Pack of 6 pcs. ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120310 - ri-pen® blue: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120341 - ri-pen® green: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120389 - ri-pen® silver: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120464 - ri-pen® black: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120525 - ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396198487 - e-xam XL 2.5 V, black: 2021-07-27 The Riester diagnostic light is used for examination.
• 04045396198562 - Pack of 6 pcs. ri-pen®, violett: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.