FDA Registration
Active
🇨🇦 Canada
PRIMED INSTRUMENTS, INC.
Reg #: 9680488
·
FEI: 3002642300
·
Expires 2026
Products
5
Proprietary Names
26
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- PRIMED INSTRUMENTS, INC.
- Registration Number
- 9680488
- FEI Number
- 3002642300
- Status
- Active
- Expiry Year
- 2026
- 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
- TOBIAS SYSTEM, LLC
- Contact Name
- Katie 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 |
|---|---|---|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2017-08-25 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2019-12-09 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2004-10-04 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-12-09 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 1994-02-02 |
Proprietary Names
Single Use Grasping Forceps
Single Use Retrieval Device
Baron Suction Tube Brush
Double-Ended Cleanable Brush
Blue Stiff-Line Cleaning Brush
Double-Ended Valve Brush
Large Cleaning Brush
Instrument Cleaning Brush
Single-Ended Cleanable Brush
Single-Ended Valve Brush
Large Instrument Brush
Frazier Suction Tube Brush
Double-Ended (Acetabular) Reamer Brush
Cannula Cleaning Brush
Cleaning Brush
Double-Ended Cleaning Brush
Nylon Twisted Wire Cleaning Brush
SuperDART® Pull Through Channel Cleaning Device with Squeegee Wiper
DART® Endoscope Channel Cleaning Brush
Disposable Channel Brushes
Reusable Channel Brushes
NoSpill Containers Tray
Formalin Containers Holding/Storage Tray
MultiCROC Single-Use Multiple Biopsy Forceps
MultiCROC Multi-Sampling Single-Use Biopsy Forceps
Single Use Biopsy Forceps
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)