Xpress BCD LLC

GUDID 00860008878328

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

Radiological breast positioner haemostatic compression attachment
Primary Device ID00860008878328
NIH Device Record Key314d1a98-d6a4-4bbc-9c20-6dfbf7f5c790
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpress BCD LLC
Version Model NumberPyramidal
Company DUNS047751363
Company NameXpress Bcd LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com
Phone3014015853
Emailinfo@xpressbcd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008878328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

POYPost Breast Biopsy Hemostatic Breast Compression Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-15
Device Publish Date2023-05-05

On-Brand Devices [Xpress BCD LLC]

00860008878335This is a pack of three XPress BCD devices (Flat, Spherical, Pyramidal) with varying surface are
00860008878328The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy dev
00860008878311The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy dev
00860008878304The XPress BCD (breast compression device) is used in conjunction stereotactic breast biopsy dev

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