FDA Registration
Active
🇨🇦 Canada
Reusable Channel Brushes
Reg #: 9680488
·
FEI: 3002642300
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRIMED INSTRUMENTS, INC.
- Registration Number
- 9680488
- FEI Number
- 3002642300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1080 TRISTAR DR., UNIT 11, 13 & 14
- City
- MISSISSAUGA Ontario
- Country
- CA
Owner / Operator
- Firm Name
- PRIMED INSTRUMENTS, INC.
- Operator Number
- 9009402
- Address
- 1080 TRISTAR DR., UNIT 14, --
- City
- MISSISSAUGA, ONTARIO
- State
- CA-NOTA
- Postal Code
- L5T 1P1
- Country
- CA
- Correspondent
- JACK - KRZYZANOWSKI
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2004-10-04 |
Proprietary Names
Reusable Channel Brushes
SuperDART® Pull Through Channel Cleaning Device with Squeegee Wiper
Disposable Channel Brushes
DART® Endoscope Channel Cleaning Brush
Establishment Types
Manufacture Medical Device