SuperVu XL Advantage 3.5x, at 42cm working distanc 3981-635

GUDID 04045396160774

Riester binocular loupes are used to enlarge the examination field.

Rudolf Riester GmbH

Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable

• Primary Device ID: 04045396160774
• NIH Device Record Key: 1cf6cd4e-1584-4516-89b7-8623c2a013f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperVu XL Advantage 3.5x, at 42cm working distanc
• Version Model Number: 3981-635
• Catalog Number: 3981-635
• Company DUNS: 537208717
• Company Name: Rudolf Riester GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04045396160774 [Primary]

FDA Product Code

• HJH: Loupe, Binocular, Low Power

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: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by Rudolf Riester GmbH

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• 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.
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• 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.