FDA Registration
Active
🇨🇦 Canada
ARBUTUS MEDICAL, INC
Reg #: 3013004243
·
FEI: 3013004243
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ARBUTUS MEDICAL, INC
- Registration Number
- 3013004243
- FEI Number
- 3013004243
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2520 Columbia St
- City
- Vancouver British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K203605
Owner / Operator
- Firm Name
- Arbutus Medical, Inc
- Operator Number
- 10051759
- Address
- 2520 Columbia St.
- City
- Vancouver
- State
- British Columbia
- Postal Code
- V5Y 3E9
- Country
- CA
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2023-01-23 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-08-09 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2021-03-08 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-04-29 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2021-08-09 |
Proprietary Names
QuikBow
SteriTrak System
TrakPak
Skeletal Traction Procedure Kit
Foot Debridement SwiftKit
Digit Revision SwiftKit
Nailbed Repair SwiftKit
DrillCover Hex System
SawCover System
DrillCover PRO System
SteriTrak Drill
Establishment Types
Manufacture Medical Device