ri-scope® ophthalmoscope head L3 LED 2,5 V 10598

GUDID 04045396209282

The Riester ophthalmoscope is produced for the examination of the eye and the eyeground.

Rudolf Riester GmbH

Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set Ophthalmic/otologic diagnostic set

• Primary Device ID: 04045396209282
• NIH Device Record Key: bb41aabd-5e99-4390-990f-cfc8b3f23cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-scope® ophthalmoscope head L3 LED 2,5 V
• Version Model Number: 10598
• Catalog Number: 10598
• 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	04045396209282 [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.