Tracey-VFA Visual Function Analyzer Z2000

GUDID 00860479001706

The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.

TRACEY TECHNOLOGIES, CORPORATION

Corneal topography system

• Primary Device ID: 00860479001706
• NIH Device Record Key: 35035323-c3d7-43c3-a039-eed05c58af81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracey-VFA Visual Function Analyzer
• Version Model Number: iTrace
• Catalog Number: Z2000
• Company DUNS: 027572366
• Company Name: TRACEY TECHNOLOGIES, 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	00860479001706 [Primary]

FDA Product Code

• NCF: Aberrometer, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2020-01-09