FDA Registration
Active
🇨🇦 Canada
Gamma Centre of Excellence
Reg #: 3010131578
·
FEI: 3010131578
·
Expires 2026
Products
10
Proprietary Names
10
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Gamma Centre of Excellence
- Registration Number
- 3010131578
- FEI Number
- 3010131578
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 535 Cartier Boulevard Ouest
- City
- Laval Quebec
- Country
- CA
Owner / Operator
- Firm Name
- Nordion Canada Inc.
- Operator Number
- 8022247
- Address
- 447 MARCH RD., --
- City
- OTTAWA
- State
- Ontario
- Postal Code
- K2K1X8
- Country
- CA
- Correspondent
- Natalie - Girard
US Agent
- Business Name
- Sterigenics
- Contact Name
- Chris Eustace
- Address
- 2015 Spring Rd Ste 650
- City
- Oak Brook
- State
- IL
- ZIP
- 60523
- Country
- US
- [email protected]
- Phone
- 630 9281700
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-08-14 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2023-04-26 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2023-04-26 |
| Transport Systems, Anaerobic | JTX | Class 1 | Microbiology | No | 2023-04-26 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2023-04-26 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-07-26 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2024-08-14 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2024-08-14 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-08-14 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-08-26 |
Proprietary Names
Pin Kaps
Puritan Fecal Opti-swab Collection and Transport System
Puritan Liquid Amies Swab Collection and Transport System
Exsalt CMC Gelling Fiber Dressing
Clamp Covers; Vascular Silicone Ties
Batrik Medical Manufacturing Inc
Non-Sterile Cautery Tip Cleaner; Suture Clamp Tags
Exsalt T7 Wound Dressing
Fassier-Duval Telescopic IM System
Exsalt PT7 Contact Layer
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)