Biopsy needles
DualCore Biopsy System-12g x 16cm 5pk
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.
DualCore Biopsy System-12g x 16cm 5pk 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 |
|---|---|---|---|
| MCN1210 | Length 10 cm | Not stated | Available |
| MCN1216 | Length 16 cm | Not stated | Available |
| MCN1410 | Length 10 cm | Not stated | Available |
| MCN1416 | Length 16 cm | Not stated | Available |
| MCN1610 | Length 10 cm | Not stated | Available |
| MCN1616 | Length 16 cm | Not stated | Available |
FDA clearances
- 510(k) K973565 November 1997
Procedures that use biopsy needles
Frequently asked questions
What is DualCore Biopsy System-12g x 16cm 5pk 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 DualCore Biopsy System-12g x 16cm 5pk?
DualCore Biopsy System-12g x 16cm 5pk is made by Izi Medical Products, LLC. It is listed under biopsy needles and systems in our device library.
What sizes does DualCore Biopsy System-12g x 16cm 5pk come in?
Sizes listed for DualCore Biopsy System-12g x 16cm 5pk: Length: 10–16 cm. Confirm availability with the manufacturer's instructions for use.
Is DualCore Biopsy System-12g x 16cm 5pk MRI safe?
The FDA device database entry for DualCore Biopsy System-12g x 16cm 5pk does not state its MRI safety status. Check the labeling before MRI.
Is DualCore Biopsy System-12g x 16cm 5pk FDA cleared?
DualCore Biopsy System-12g x 16cm 5pk is covered by FDA submission K973565.
How do I contact a Izi Medical Products, LLC sales representative?
Izi Medical Products, LLC has not listed representatives on LA Vascular yet. Visit the Izi Medical Products, LLC 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.