Seiler Precision Microscopes
Basic Information
- Brand Name
- Seiler Precision Microscopes
- Primary DI
- 00852728008079
- Version / Model
- 3DV-100
- Company Name
- SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED
- Labeler DUNS
- 006265334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 4faf7264-ae4d-48e6-bf76-f33a8b8af2ee
Device Description
The 3D Surgical Microscopes are produced and sold by Seiler Instrument & Manufacturing Co., Inc. There are many types of medical procedures that benefit from the high magnification provided by a surgical microscope. The microscope offers the user an illuminated and magnified view of the field of interest. Floor, Wall, and Ceiling support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes a LED light source to illuminate the area within the field of view. A light guide/cable transfers the output from the light source to the optic pod. The light is then projected through the objective lens to the area of interest, providing relatively shadow-free illumination. The light source also provides two DC outputs to provided power to the 3D display and other electronics. The user must wear polarized 3D glasses while viewing the 3D display to view the illuminated and magnified view of the field of interest. Focus, magnification, and brightness controls offer image options to the user.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EPT | Microscope, Surgical | 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 | 00852728008079 | GS1 |