Biopsy needles
Maxx-Cell
by Ranfac Corp.
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Maxx-Cell 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 |
|---|---|---|---|
| 11GA X 11CM | Needle Gauge 11 G; Length 11 cm; Needle Gauge 8 G; Length 15 cm | Not stated | Available |
FDA clearances
- 510(k) K150563 May 2015
Procedures that use biopsy needles
Frequently asked questions
What is Maxx-Cell used for?
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Who makes Maxx-Cell?
Maxx-Cell is made by Ranfac Corp.. It is listed under biopsy needles and systems in our device library.
What sizes does Maxx-Cell come in?
Sizes listed for Maxx-Cell: Needle Gauge: 8–11 G; Length: 11–15 cm. Confirm availability with the manufacturer's instructions for use.
Is Maxx-Cell MRI safe?
The FDA device database entry for Maxx-Cell does not state its MRI safety status. Check the labeling before MRI.
Is Maxx-Cell FDA cleared?
Maxx-Cell is covered by FDA submission K150563.
How do I contact a Ranfac Corp. sales representative?
Ranfac Corp. has not listed representatives on LA Vascular yet. Visit the Ranfac Corp. 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.