FDA UDI
In Commercial Distribution
🇺🇸 United States
Labomed Prima OPH microscope (Basic, motorized fine focus)
DI: 08908006463312
·
Model: 6136000
·
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Labomed Prima OPH microscope (Basic, motorized fine focus)
- Primary DI
- 08908006463312
- Version / Model
- 6136000
- Company Name
- LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
- Labeler DUNS
- 919049606
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-15
- Public Version
- 1
- Public Version Date
- 2023-06-23
- Public Version Status
- New
- Public Device Record Key
- 075d8792-d213-4a06-9ca6-1faefb6b76a1
Device Description
- MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - RedReflex optical system - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 45° inclined binocular head, IPD 55-75mm - f=200mm CMO - WF 10x/16mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360° rotation) and suspension arm (600mm Long, 320° rotation) with locking/tension control knobs and LED shut-off in park position - Z-Axis motorized fine focus - Floor stand with H-shape base on castor wheels with brakes - Blue and Green sliding filters, dust cover, and sterilizable knob caps
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 | 08908006463312 | GS1 |