Biopsy needles
Medem
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.
Medem 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 |
|---|---|---|---|
| MD15040-00 | — | MR Unsafe | Available |
| MD15050-00 | — | MR Unsafe | Available |
| MD15060-00 | — | MR Unsafe | Available |
| MD16040-00 | — | MR Unsafe | Available |
| MD16050-00 | — | MR Unsafe | Available |
| MD16060-00 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K172344 November 2017
Procedures that use biopsy needles
Frequently asked questions
What is Medem 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 Medem?
Medem is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does Medem come in?
The FDA device database does not list sizes for Medem. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is Medem MRI safe?
The FDA device database lists Medem as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Medem FDA cleared?
Medem is covered by FDA submission K172344.
How do I contact a Medax Srl Unipersonale sales representative?
Medax Srl Unipersonale has not listed representatives on LA Vascular yet. Visit the Medax Srl Unipersonale 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.