FDA Registration
Active
🇺🇸 United States
OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
Reg #: 3008262715
·
FEI: 3008262715
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Varian Medical Systems, Inc
- Registration Number
- 3008262715
- FEI Number
- 3008262715
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9825 Spectrum Drive, Building 2
- City
- Austin
- State
- TX
- ZIP
- 78717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230015
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-09-04 |
Proprietary Names
OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198