Biopsy needles
OmniBone Bone Biopsy Kit with 11 Gauge 68mm length
by Varian Medical Systems, Inc.
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.
OmniBone Bone Biopsy Kit with 11 Gauge 68mm length models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| OMB11/6.5 | — | MR Unsafe | Available |
| OMB11/10 | — | MR Unsafe | Available |
| OMB 11/15 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K230015 June 2023
Procedures that use biopsy needles
Frequently asked questions
What is OmniBone Bone Biopsy Kit with 11 Gauge 68mm length used for?
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.
Who makes OmniBone Bone Biopsy Kit with 11 Gauge 68mm length?
OmniBone Bone Biopsy Kit with 11 Gauge 68mm length is made by Varian Medical Systems, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does OmniBone Bone Biopsy Kit with 11 Gauge 68mm length come in?
The FDA device database does not list sizes for OmniBone Bone Biopsy Kit with 11 Gauge 68mm length. Check the instructions for use or ask a Varian Medical Systems, Inc. representative.
Is OmniBone Bone Biopsy Kit with 11 Gauge 68mm length MRI safe?
The FDA device database lists OmniBone Bone Biopsy Kit with 11 Gauge 68mm length as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is OmniBone Bone Biopsy Kit with 11 Gauge 68mm length FDA cleared?
OmniBone Bone Biopsy Kit with 11 Gauge 68mm length is covered by FDA submission K230015.
How do I contact a Varian Medical Systems, Inc. sales representative?
Varian Medical Systems, Inc. has not listed representatives on LA Vascular yet. Visit the Varian Medical Systems, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.