Biopsy needles
Monoject
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.
Monoject 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 |
|---|---|---|---|
| SC2013X | Length 2 in | Not stated | Available |
| SC3513X | Length 3 in | Not stated | Available |
| SC4011X | Length 4 in | Not stated | Available |
| SC5008X | Length 5 in; Needle Gauge 8 G | Not stated | Available |
| SC6011X | Length 6 in; Needle Gauge 11 G | Not stated | Available |
FDA clearances
- 510(k) K983187 December 1998
Procedures that use biopsy needles
Frequently asked questions
What is Monoject 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 Monoject?
Monoject is made by Cardinal Health, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Monoject come in?
Sizes listed for Monoject: Length: 2–6 in; Needle Gauge: 8–11 G. Confirm availability with the manufacturer's instructions for use.
Is Monoject MRI safe?
The FDA device database entry for Monoject does not state its MRI safety status. Check the labeling before MRI.
Is Monoject FDA cleared?
Monoject is covered by FDA submission K983187.
How do I contact a Cardinal Health, Inc. sales representative?
Cardinal Health, Inc. has not listed representatives on LA Vascular yet. Visit the Cardinal Health, 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.