XPRESS BCD LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3026674642	3026674642	XPRESS BCD LLC	1	N	2026-01-01	6024 White Flint Drive Frederick MD US 21702

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00860008878304	Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has a spherical surface area to apply focused pressure to the center point.	3014015853	info@xpressbcd.com
00860008878311	Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has a flat surface area.	3014015853	info@xpressbcd.com
00860008878328	Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has an offset pyramidal surface area to apply increased pressure to an offset point.	3014015853	info@xpressbcd.com

xpressbcd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
315197	2019834776	K163388	XPress BCD Breast Compression Device	POY	2017-07-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
POY	1	2017-07-19

GUDID#

Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has a spherical surface area to apply focused pressure to the center point.
Xpress Bcd LLC
2023-05-05
Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has a flat surface area.
Xpress Bcd LLC
2023-05-05
Xpress BCD LLC - The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy devices. The primary function of the device is 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. This model has an offset pyramidal surface area to apply increased pressure to an offset point.
Xpress Bcd LLC
2023-05-05
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.
Xpress Bcd LLC
2023-05-05