Xpress BCD Breast Compression Device

Basic Information

• Brand Name: Xpress BCD Breast Compression Device
• Primary DI: 00810105030501
• Version / Model: BCD-001
• Company Name: COMPOSITE MANUFACTURING, INC.
• Labeler DUNS: 947090650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-16
• Public Version: 1
• Public Version Date: 2021-04-26
• Public Version Status: New
• Public Device Record Key: a7c80012-b762-460a-8ef7-75ab81f23644

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POY	Post Breast Biopsy Hemostatic Breast Compression Device	Radiology	892.1710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40926	Mammographic x-ray system compression paddle	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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810105030501	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]