Xpress BCD Breast Compression Device

GUDID 00810105030501

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.

COMPOSITE MANUFACTURING, INC.

Mammographic x-ray system compression device

• Primary Device ID: 00810105030501
• NIH Device Record Key: a7c80012-b762-460a-8ef7-75ab81f23644
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpress BCD Breast Compression Device
• Version Model Number: BCD-001
• Company DUNS: 947090650
• Company Name: COMPOSITE MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com
• Phone: 949-361-7580
• Email: info@carbonfiber.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810105030501 [Primary]

FDA Product Code

• POY: Post Breast Biopsy Hemostatic Breast Compression Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

Devices Manufactured by COMPOSITE MANUFACTURING, INC.

• 00810105030754 - Adult Arm and Hand Table, No Pad: 2024-05-21 Carbon fiber construction radiolucent surgical table attachment sized for adult patients. Attached to surgical table side rails
• 00810105030761 - Pediatric Arm and Hand Table No Pad: 2024-05-21 Carbon fiber construction radiolucent surgical table attachment sized for pediatric patient. Attachment to surgical table side r
• 00810105030778 - Microsurgical Arm and Hand Table No Pad: 2024-05-21 Carbon fiber construction radiolucent surgical table attachment sized for pediatric patients. Attached to surgical table side ra
• 00810105030730 - CMI Spine Frame Head Foam Supports (12 Pack): 2024-05-03 Pack of Head Foam Supports for CMI Spine Frame.
• 00810105030747 - CMI Spine Frame Arm Covers (12 Pack): 2024-05-03 Pack of Arm Covers for CMI Spine Frame.
• 00810105030723 - Multi Posture Armboard Kit: 2024-04-11 Multi Position Armboard designed to integrate with surgical table side rail and support the patient arm for surgical procedures.
• 00810105030587 - Trigger Lite Armboard: 2024-04-01 Carbon Fiber construction Armboard designed to integrate with surgical table side rail and support the patient arm for surgical
• 00810105030594 - Trigger Lite Armboard Pad 2": 2024-04-01 2" Thick Pad for Trigger Lite Armboard