FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical 3D Video Microscope KestrelView II
DI: 04589698450206
·
Model: KV2
·
MITAKA KOHKI CO., LTD.
Product Codes
1
GMDN Terms
6
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surgical 3D Video Microscope KestrelView II
- Primary DI
- 04589698450206
- Version / Model
- KV2
- Company Name
- MITAKA KOHKI CO., LTD.
- Labeler DUNS
- 692666613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-03
- Public Version
- 2
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- ce95be3b-e296-4562-b9f6-741a80909d43
Device Description
The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 12538 | ENT surgical microscope | A light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. It is usually held by an adjustable arm attached to the support mechanism and equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes. Dual- or multiple-observation capability and the optical integration of still, motion picture, and TV cameras are common features. | No | Active |
| 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 |
| 37184 | Microscope objective | A lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification. | No | Active |
| 41596 | Surgical microscope stand | A mobile device onto which a surgical microscope (not included) is designed to be mounted/secured to enable dynamic positioning of the surgical microscope during surgical procedures. It is designed as a floor stand with a vertical base on wheels and typically with articulated arms that connect to the microscope; in addition, various microscope functions may be controlled from the mount such as movement (motor-assisted), light intensity, zoom, or colour balance. | No | Obsolete |
| 41895 | Neurosurgical microscope | A light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It 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 is usually fixed. | No | Active |
| 57883 | Surgical microscope fluorescent angiography system | A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04589698450206 | GS1 |