Xpress BCD LLC

Basic Information

• Brand Name: Xpress BCD LLC
• Primary DI: 00860008878335
• Version / Model: Inner Pack
• Company Name: Xpress Bcd LLC
• Labeler DUNS: 047751363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 1
• Public Version Date: 2023-05-15
• Public Version Status: New
• Public Device Record Key: 6a16f3bb-958d-4052-ab69-3fc2f287c47f

Device Description

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.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
66761	Radiological breast positioner haemostatic compression attachment	A noninvasive device intended to be attached to a radiological breast positioner (e.g., paddle) to provide pressure and achieve haemostasis to the breast. It is intended to be used with a dressing (e.g., gauze) after an image-guided surgical or interventional procedure (e.g., biopsy); the positioner and dressing are not included. It is typically in the form of a small block with various compression surface configurations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008878335	GS1
Package	10860008878332	GS1	Cardboard box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163388	000