FDA UDI
In Commercial Distribution
🇺🇸 United States
SeeLuma
DI: 04064434000124
·
Model: V12100-01
·
Munich Surgical Imaging GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeeLuma
- Primary DI
- 04064434000124
- Version / Model
- V12100-01
- Company Name
- Munich Surgical Imaging GmbH
- Labeler DUNS
- 315155571
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-24
- Public Version
- 1
- Public Version Date
- 2024-06-03
- Public Version Status
- New
- Public Device Record Key
- 7b781f41-8afb-47ed-8648-b3d26d25ab62
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64676 | Ophthalmic surgical microscope | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04064434000124 | GS1 |