FDA Registration
Active
🇨🇦 Canada
SPY-PHI System
Reg #: 3012345110
·
FEI: 3012345110
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Novadaq Technologies ULC
- Registration Number
- 3012345110
- FEI Number
- 3012345110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8329 Eastlake Drive, Unit 101
- City
- Burnaby British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K200737
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2020-07-13 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2020-07-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-07-13 |
Proprietary Names
SPY-PHI System
Pinpoint Light Cable
SPY Portable Handheld Imaging (SPY-PHI) System
Video Processor / Illuminator VPI
SPY-PHI Handheld Imager
Establishment Types
Manufacture Medical Device