CATS Tonometer

GUDID 00860412001510

The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism that is optimized to work with the GAT's operating system to reduce errors in the measurement due to patient anatomical variation. This is used to measure intraocular pressure by applying a known force on the globe of the eye and measuring intraocular tension by applanation. Tonometer prisms are assembled onto a GAT as a patient contacting component that is then utilized by the GAT to assess intraocular pressure.

ZIEN MEDICAL TECHNOLOGIES, INC.

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• Primary Device ID: 00860412001510
• NIH Device Record Key: 2299df90-c01c-4689-9043-f11e8516a6fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATS Tonometer
• Version Model Number: CATS-R
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• 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: false
• 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	00860412001510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173904

FDA Product Code

• HKY: Tonometer, Manual

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: 2020-02-04
• Device Publish Date: 2020-01-27

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