IGI
Basic Information
- Brand Name
- IGI
- Primary DI
- 07290016855012
- Version / Model
- A-IG-0005-V1.5
- Catalog Number
- A-IG-0005-V1.5
- Company Name
- IMAGE NAVIGATION LTD
- Labeler DUNS
- 532112401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-26
- Public Version
- 1
- Public Version Date
- 2020-12-04
- Public Version Status
- New
- Public Device Record Key
- db2b2e7e-d1dc-46f7-81b6-760977c0864c
Device Description
The Image-Guided Implantation system is an image-guided surgery system, designed to provide guidance of surgical instruments used in dental implantation procedures. The system implements the well-established advances in the fields of computer-aided surgery and image-guided surgery into the field of dental implantology. The IGI-system provides accurate guidance of the surgical instruments with regard to the patient’s anatomical structures and to the pre-surgical plan, based on the patient’s CT imaging. The system is an infra-red optics-based navigational system, which utilizes an infra-red camera sensor and light-emitting diodes (LEDs) to monitor objects in a defined space. The system comprises of the following components: computer processing unit, monitor, tracking camera and trackable appliances (designed to monitor the surgical hand-piece and patient position).
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45197 | Dental stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016855012 | GS1 |
Customer Contacts
- Phone
- +97226417748
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal