econom® Vac. 2.7 V / XL 2.5 V, C-handle 2050

GUDID 04045396002760

The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum. The Riester ophthalmoscope has been designed for the examination of the eye and its background.

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: 04045396002760
• NIH Device Record Key: d01d4244-6964-454e-9517-e8b2df4d0c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: econom® Vac. 2.7 V / XL 2.5 V, C-handle
• Version Model Number: 2050
• Catalog Number: 2050
• 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	04045396002760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925754

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

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.