SeeLuma

GUDID 04064434000124

The medical device is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries. The system provides interfaces via which image, OCT and other data can be imported and exported.

Munich Surgical Imaging GmbH

Ophthalmic surgical microscope

• Primary Device ID: 04064434000124
• NIH Device Record Key: 7b781f41-8afb-47ed-8648-b3d26d25ab62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeeLuma
• Version Model Number: V12100-01
• Company DUNS: 315155571
• Company Name: Munich Surgical Imaging GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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	04064434000124 [Primary]

FDA Product Code

• HRM: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

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: 2024-06-03
• Device Publish Date: 2024-05-24

On-Brand Devices [SeeLuma]

• 04064434000117: The ophthalmic microscope is a surgical microscope designed for the illumination and magnificati
• 04064434000124: The medical device is a surgical microscope designed for the illumination and magnification of t