Luneau

GUDID 03664188000114

The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.

LUNEAU TECHNOLOGY OPERATIONS

Ophthalmic tonometer tip cover

• Primary Device ID: 03664188000114
• NIH Device Record Key: ed4a9b04-4d56-444f-a6a2-c9f1d6019d6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luneau
• Version Model Number: Tonometer separation prisms L900 -box of 20
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Device Count: 100
• 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	03664188000114 [Unit of Use]
GS1	03664188000138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023838

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: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [Luneau]

• 03664188000107: The separation prisms is an accessory to the tonometer which is device intended to estimate intr
• 03664188000114: The separation prisms is an accessory to the tonometer which is device intended to estimate intr
• 03664188000312: Measurement of corneal sensation, specifically tactile.