RODENSTOCK

GUDID 03664188000930

LUNEAU TECHNOLOGY OPERATIONS

Automated ophthalmic refractometer

• Primary Device ID: 03664188000930
• NIH Device Record Key: a4817618-65df-49c7-a090-dff30959029c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RODENSTOCK
• Version Model Number: DNEye Scanner 2+
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• 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	03664188000930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162067

FDA Product Code

• HKX: Tonometer, Ac-Powered

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

On-Brand Devices [RODENSTOCK]

• 03664188000930: DNEye Scanner 2+
• 03664188000923: The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combine