ri-vision with slit retinoscope XL/LED 3,5V, C han 3821-203

GUDID 04045396182783

The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye.

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: 04045396182783
• NIH Device Record Key: a1f0d08f-7661-4ff3-8877-cdcf2cb4273c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-vision with slit retinoscope XL/LED 3,5V, C han
• Version Model Number: 3821-203
• Catalog Number: 3821-203
• 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	04045396182783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964338

FDA Product Code

• HKM: Retinoscope, 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

On-Brand Devices [ri-vision with slit retinoscope XL/LED 3,5V, C han]

• 04045396182783: The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (
• 04045396182646: The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (