Cornea/Anterior Segment OCT

GUDID 04582273604704

TOMEY CORPORATION.

Ophthalmic spectral-domain optical coherence tomography system

• Primary Device ID: 04582273604704
• NIH Device Record Key: 082d5419-88da-49a7-8dd8-2927ac638fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cornea/Anterior Segment OCT
• Version Model Number: CASIA2
• Company DUNS: 696280002
• Company Name: TOMEY CORPORATION.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582273604704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213265

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by TOMEY CORPORATION.

• 04582273604704 - Cornea/Anterior Segment OCT: 2023-06-15
• 04582273604704 - Cornea/Anterior Segment OCT: 2023-06-15
• 04582273600218 - AUTO REFKERATOMETER: 2022-04-11
• 04582273600256 - AUTO REF-TOPOGRAPHER: 2022-04-11
• 04582273600263 - NON-CONTACT TONOMETER: 2022-04-11
• 04582273603691 - SPECULAR MICROSCOPE: 2022-04-11
• 04582273603714 - Topographic Modeling System: 2022-04-11
• 04582273604162 - Auto Lensmeter: 2022-04-11
• 04582273611788 - AUTO REFKERATOMETER: 2022-04-11