Labomed Magna Ceiling mount with motorized filter (Long arm)
Basic Information
- Brand Name
- Labomed Magna Ceiling mount with motorized filter (Long arm)
- Primary DI
- 08908006463176
- Version / Model
- 6129202
- 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
- 2022-12-15
- Public Version
- 1
- Public Version Date
- 2022-12-23
- Public Version Status
- New
- Public Device Record Key
- 89dd9b33-765c-428d-95cb-b34f62697e0b
Device Description
LABOMED Magna is a surgical and diagnostic microscope that is adaptable for different surgical needs for consistent visualization during all intraoperative phases of endodontics by providing a magnified view of the surgical field without compromising performance. The microscope provides extremely high optical image quality, good depth of focus, and a wide field of view for precise surgery. Illumination control and high eye point of the observation head helps reduce the user's work fatigue and allows comfortable use over a long period. Salient features of this microscope are: 1. The observation head can easily be positioned with the help of a suspension arm. 2. An advanced Galilean Zoom 1:6, also convertible to 8 step magnichanger allows optimal magnification for various needs at different magnification levels. 3. Cold light illumination with a high intensity 50W LED lamp is provided using a fiber optic guide for proper illumination. 4. An effortless articulating system ABA (Automatic Balancing Arm) features an electromagnetic brake system that enables the ultimate flexibility in manuvering the microscope's viewing angle and position. 5. The Labomed NuVar CMO with variable working distance objective comes standard, and provides user greater convenience in achieving a comfortable working distance. 6. The rigid Cross base with caster wheels provides the instrument with stability and mobility. 7. When the microscope is not in use, the suspension arm can be folded over the main body for compact storage. 8.Motorized filter. Intended Use: The Magna microscope is an AC powered device intended for use during diagnosis and surgery to provide a magnified view of the region of interest.
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 | 08908006463176 | GS1 |