Biopsy needles
Medone Ultra
A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Medone Ultra 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 |
|---|---|---|---|
| MU12100-00 | — | MR Unsafe | Available |
| MU12100-K0 | — | MR Unsafe | Available |
| MU12120-00 | — | MR Unsafe | Available |
| MU12120-C0 | — | MR Unsafe | Available |
| MU12120-K0 | — | MR Unsafe | Available |
| MU12160-00 | — | MR Unsafe | Available |
| MU12160-K0 | — | MR Unsafe | Available |
| MU12200-00 | — | MR Unsafe | Available |
| MU12200-K0 | — | MR Unsafe | Available |
| MU14100-00 | — | MR Unsafe | Available |
| MU14100-K0 | — | MR Unsafe | Available |
| MU14120-00 | — | MR Unsafe | Available |
| MU14120-C0 | — | MR Unsafe | Available |
| MU14120-K0 | — | MR Unsafe | Available |
| MU14160-00 | — | MR Unsafe | Available |
| MU14160-K0 | — | MR Unsafe | Available |
| MU14200-00 | — | MR Unsafe | Available |
| MU14200-K0 | — | MR Unsafe | Available |
| MU16100-00 | — | MR Unsafe | Available |
| MU16100-K0 | — | MR Unsafe | Available |
| MU16120-00 | — | MR Unsafe | Available |
| MU16160-00 | — | MR Unsafe | Available |
| MU16160-K0 | — | MR Unsafe | Available |
| MU16200-00 | — | MR Unsafe | Available |
| MU16200-K0 | — | MR Unsafe | Available |
| MU18100-00 | — | MR Unsafe | Available |
| MU18100-K0 | — | MR Unsafe | Available |
| MU18160-00 | — | MR Unsafe | Available |
| MU18160-K0 | — | MR Unsafe | Available |
| MU18200-00 | — | MR Unsafe | Available |
| MU18200-K0 | — | MR Unsafe | Available |
| MU18250-K0 | — | MR Unsafe | Available |
| MU20100-00 | — | MR Unsafe | Available |
| MU20100-K0 | — | MR Unsafe | Available |
| MU20160-00 | — | MR Unsafe | Available |
| MU20160-K0 | — | MR Unsafe | Available |
| MU20200-00 | — | MR Unsafe | Available |
| MU20200-K0 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K192101 April 2020
Procedures that use biopsy needles
Frequently asked questions
What is Medone Ultra used for?
A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Who makes Medone Ultra?
Medone Ultra is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does Medone Ultra come in?
The FDA device database does not list sizes for Medone Ultra. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is Medone Ultra MRI safe?
The FDA device database lists Medone Ultra as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Medone Ultra FDA cleared?
Medone Ultra is covered by FDA submission K192101.
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.