Labomed Prima ENT microscope
Basic Information
- Brand Name
- Labomed Prima ENT microscope
- Primary DI
- 08908006463008
- Version / Model
- 6137000
- 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
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 6facb408-2cd2-4365-972c-6daa4f59b792
Device Description
Prima ENT microscope - MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - Straight binocular head, IPD 50-75mm - f=250mm CMO with manual fine focus knob and sterilizable cap - WF 10x/18mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360 degree rotation) and suspension arm (600mm Long, 320 degree rotation) with locking/tension control knobs and LED shut-off in park position - Carrier arm and 120 degree coupling with tension adjustment locks, T-handle /Ergo Handle control - Floor stand with H-shape base on castor wheels with brakes - Yellow 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 |
|---|---|---|---|---|
| FSO | Microscope, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35191 | General-purpose surgical microscope | A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908006463008 | GS1 |