FDA Registration
Active
🇨🇦 Canada
Pivot Implant Extraction Osteotome System
Reg #: 3020767943
·
FEI: 3020767943
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- RP MEDICAL INC.
- Registration Number
- 3020767943
- FEI Number
- 3020767943
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 360 Long Ridge Drive
- City
- Kelowna British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K181845
Owner / Operator
- Firm Name
- RP Medical Inc.
- Operator Number
- 10083048
- Address
- 360 Long Ridge Drive
- City
- Kelowna
- State
- British Columbia
- Postal Code
- V1V 2R9
- Country
- CA
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-10-21 |
Proprietary Names
Pivot Implant Extraction Osteotome System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device