Device
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 i...
Manufacturer
Munich Surgical Imaging GmbH
Munich Surgical Imaging GmbH
Model: V12403-01
DI: 04064434000209
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a9b7a74d-04f1-4f8d-bcb1-12ed366c4d1d
Distribution Status:
In Commercial Distribution
DUNS Number:
315155571
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04064434000209
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64676
Name: Ophthalmic surgical microscope
Definition:
An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens.
FDA Product Codes
HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic