KR-1W Viewer

GUDID 04560126266071

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

• Primary Device ID: 04560126266071
• NIH Device Record Key: eb3c3275-56bc-41e5-ae9c-78af544b5bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KR-1W Viewer
• Version Model Number: KR-1W Viewer
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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	04560126266071 [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: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by TOPCON CORPORATION

• 04562123288384 - COMPUTERIZED LENSMETER CL-300: 2023-12-27
• 04562123288391 - COMPUTERIZED LENSMETER CL-300: 2023-12-27
• 04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos: 2023-11-24
• 04560126264640 - INFRARED COMMUNICATION UNIT: 2022-09-08
• 04560126266071 - KR-1W Viewer: 2022-09-08
• 04560126266071 - KR-1W Viewer: 2022-09-08
• 04562123280531 - PRISM COMPENSATOR for LENSMETER LM-8: 2022-09-08
• 04562123286441 - TL-5A: 2022-09-08
• 04562123286465 - OBLIQUE ILLUMINATOR MS-OI04: 2022-09-08