ri-vision with slit retinoscope XL/LED 3,5V, C han 3794-203

GUDID 04045396182646

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

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: 04045396182646
• NIH Device Record Key: ec8d82a7-b6ef-49be-a966-601d479964e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-vision with slit retinoscope XL/LED 3,5V, C han
• Version Model Number: 3794-203
• Catalog Number: 3794-203
• 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	04045396182646 [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 (