NON-CONTACT TONOMETER

GUDID 04582273612150

The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of

TOMEY CORPORATION.

Ophthalmic tonometer, line-powered

• Primary Device ID: 04582273612150
• NIH Device Record Key: bfb1d572-340e-4bdd-842e-abd00b2e1851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NON-CONTACT TONOMETER
• Version Model Number: FT-1000
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582273612150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073087

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [NON-CONTACT TONOMETER]

• 04582273612167: The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact measurement system
• 04582273612150: The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system
• 04582273611740: The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact measurement system
• 04582273600263: FT-1000