Biopsy needles
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm
by Varian Medical Systems, Inc.
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm 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 |
|---|---|---|---|
| OMM 11/10 | — | MR Unsafe | Available |
| OMM 11/15 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K230015 June 2023
Procedures that use biopsy needles
Frequently asked questions
What is OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm used for?
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.
Who makes OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm?
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm is made by Varian Medical Systems, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm come in?
The FDA device database does not list sizes for OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm. Check the instructions for use or ask a Varian Medical Systems, Inc. representative.
Is OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm MRI safe?
The FDA device database lists OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm FDA cleared?
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm 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.