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Xpress BCD LLC

This is a pack of three XPress BCD devices (Flat, Spherical, Pyramidal) with varying surface area shapes that are used in conjunction with stereotactic breast biopsies. The primary function of the devices are to provide effective consistent mechanical breast compression following stereotactic-guided biopsy, replacing standard manual compression of post breast biopsy sites. Reliable and effective mechanical breast compression, with equivalent clinical outcomes, reduces medical staff blood exposure and allows for significant labor savings.

Details

Device typeRadiological breast positioner haemostatic compression attachment: A noninvasive device intended to be attached to a radiological breast positioner (e.g., paddle) to provide pressure and achieve haemostasis to the breast. It is intended to be used with a dressing (e.g., gauze) after an image-guided surgical or interventional procedure (e.g., biopsy); the positioner and dressing are not included. It is typically in the form of a small block with various compression surface configurations. This is a reusable device.

FDA categoryPost Breast Biopsy Hemostatic Breast Compression Device

Device ID00860008878335

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone3014015853

Emailinfo@xpressbcd.com

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