AUTO REFRACTOMETER RM-800

GUDID 04571130282360

TOPCON CORPORATION

Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer

• Primary Device ID: 04571130282360
• NIH Device Record Key: 2ab7d7a6-2449-419b-b39d-9fc621befc66
• 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	04571130282360 [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: 2022-07-01
• Device Publish Date: 2022-06-23

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