Topographic Modeling System

GUDID 04582273603714

TOMEY CORPORATION.

Corneal topography system

• Primary Device ID: 04582273603714
• NIH Device Record Key: f5403843-6966-4d22-9aa7-0ca4e665c2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Topographic Modeling System
• Version Model Number: TMS-4N
• Company DUNS: 696280002
• Company Name: TOMEY 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582273603714 [Primary]
GS1	04582273612129 [Previous]

FDA Product Code

• MMQ: Topographer, Corneal, Ac-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: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [Topographic Modeling System]

• 04582273612129: with 31 cone
• 04582273612099: 100V
• 04582273603714: TMS-4N