CATS CATS-D

GUDID 00860412001558

The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.

ZIEN MEDICAL TECHNOLOGIES, INC.

Ophthalmic tonometer, manual

• Primary Device ID: 00860412001558
• NIH Device Record Key: b762ac31-8131-4070-b3e2-4a7f1d6ab2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATS
• Version Model Number: CATS-D
• Catalog Number: CATS-D
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00860412001541 [Primary]
GS1	00860412001558 [Package]; Contains: 00860412001541; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203850

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-20
• Device Publish Date: 2022-10-12

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

• 10858303003009 - Syntervention: 2025-10-03 SWIPER Medical Device Foam Wiper 1 Pack
• 10858303003016 - Syntervention: 2025-10-03 SWIPER Medical Device Foam Wiper 2 Pack.
• 10858303003030 - Syntervention: 2025-10-03 SWASHER Ultra Low-Lint Surgical Towel. 2 Pack, Blue
• 10858303003047 - Syntervention: 2025-10-03 SWASHER Ultra Low-Lint Surgical Towel. 4 Pack, Blue
• 10850049994993 - Syntervention: 2025-10-01 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent surgical sponge intended for use
• 10850049994986 - Syntervention: 2025-09-30 SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent surgical sponge intended for use
• B090MT20001 - MorTan: 2025-07-03 The Morgan medi-FLOW Lens
• B090MT66730 - MorTan: 2025-07-03 The Morgan mor-FLEX Lens