Home GUDID 00810105030501 Xpress BCD Breast Compression Device
Primary DI 00810105030501
Brand Xpress BCD Breast Compression Device
Company COMPOSITE MANUFACTURING, INC.
Model BCD-001
Device description The proposed device, the XPress BCD, 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.
Published 2021-04-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name POY Post Breast Biopsy Hemostatic Breast Compression Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POY Post Breast Biopsy Hemostatic Breast Compression Device Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810105030501 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810105030501 00810105030501 810105030501 0810105030501
GMDN Terms# Term, Definition table Term Definition Mammographic x-ray system compression device A mechanically, electronically or software-controlled component of a mammographic x-ray system used to flatten and stabilize the breast during mammography studies or mammography system-guided biopsy procedures. This device typically consists of paddles or plates, associated mounts, and controls.
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