Biopsy needles
Mammotome MR
by Devicor Medical Products, Inc.
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Mammotome MR 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 |
|---|---|---|---|
| MRT08S | Height 115 mm; Needle Gauge 8 G | MR Conditional | Available |
| MRT08X | Length 145 mm; Needle Gauge 8 G | MR Conditional | Available |
| MRT11S | Length 115 mm; Needle Gauge 11 G | MR Conditional | Available |
| MRT11X | Length 145 mm; Needle Gauge 11 G | MR Conditional | Available |
| MRU08S | Length 115 mm; Needle Gauge 8 G | MR Conditional | Available |
| MRU08X | Length 145 mm; Needle Gauge 8 G | MR Conditional | Available |
| MRU11S | Length 115 mm; Needle Gauge 11 G | MR Conditional | Available |
| MRU11X | Length 145 mm; Needle Gauge 11 G | MR Conditional | Available |
FDA clearances
- 510(k) K042753 November 2004
Procedures that use biopsy needles
Frequently asked questions
What is Mammotome MR used for?
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Who makes Mammotome MR?
Mammotome MR is made by Devicor Medical Products, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Mammotome MR come in?
Sizes listed for Mammotome MR: Needle Gauge: 8–11 G; Length: 115–145 mm; Height: 115 mm. Confirm availability with the manufacturer's instructions for use.
Is Mammotome MR MRI safe?
The FDA device database lists Mammotome MR as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Mammotome MR FDA cleared?
Mammotome MR is covered by FDA submission K042753.
How do I contact a Devicor Medical Products, Inc. sales representative?
Devicor Medical Products, Inc. has not listed representatives on LA Vascular yet. Visit the Devicor Medical Products, 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.