AUTO REFRACTOMETER RM-800

GUDID 04571130283374

TOPCON CORPORATION

Automated ophthalmic refractometer

• Primary Device ID: 04571130283374
• NIH Device Record Key: faf0746d-9814-4e40-ba62-e4db99fd4934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO REFRACTOMETER RM-800
• Version Model Number: RM-800
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04571130283374 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

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: 2024-05-17
• Device Publish Date: 2024-05-09

On-Brand Devices [AUTO REFRACTOMETER RM-800]

• 04571130282360: RM-800
• 04571130283374: RM-800