Labomed Magna Floor stand with Fluorescence Observation
Basic Information
- Brand Name
- Labomed Magna Floor stand with Fluorescence Observation
- Primary DI
- 08908006463404
- Version / Model
- 6129304
- 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
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- 59976ccb-4693-4664-a5ee-f81f296793fa
Device Description
Magna - Dental Microscope on Floor Stand with Fluorescence Observation Floor stand with Cross on castor wheels with brakes Galilean Zoom 1:6, convertible to 8 step magnichanger, Zoom range 0.4 - 2.5x 2x 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply 0-210 degree tiltable head, IPD 50-75mm, configured with Rotoplate, DBSi (Double beam splitter inclined), Double iris and DSLR adapter, MaxLite(TM) optics NuVar objective variable focal length 300-400mm with fine focus FL filter to visualize and repair caries WF 10x/18mm lockable eyepieces with foldable eyeguards Swivel arm (470mm Long, 360 degree rotation), suspension arm (600mm Long, 320° rotation), vertical movement of arm (+/-250mm, light cut - off in park position) ABA (Automatic Balance Arm) with dual handle electro magnetic release for easy drift free positioning Yellow and Green 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 |
|---|---|---|---|---|
| 62439 | Dental surgical microscope | A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908006463404 | GS1 |