Xpress BCD LLC

Primary DI
00860008878335
Brand
Xpress BCD LLC
Company
Xpress Bcd LLC
Model
Inner Pack
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.
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POYPost Breast Biopsy Hemostatic Breast Compression Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POYPost Breast Biopsy Hemostatic Breast Compression DeviceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163388000XPress BCD Breast Compression DeviceXpress Bcd, LLC2017-07-19POY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860008878332PackageGS11In Commercial Distribution
00860008878335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000887833210860008878332
00860008878335008600088783358600088783350860008878335

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner haemostatic compression attachmentA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3014015853info@xpressbcd.com

Regulatory Flags#

DUNS number
047751363
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008878304Xpress BCD LLCSpherical2023-05-05
00860008878311Xpress BCD LLCFlat2023-05-05
00860008878328Xpress BCD LLCPyramidal2023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008878304Xpress BCD LLCXpress Bcd LLCPOY2023-05-05
00860008878311Xpress BCD LLCXpress Bcd LLCPOY2023-05-05
00860008878328Xpress BCD LLCXpress Bcd LLCPOY2023-05-05
00810105030501Xpress BCD Breast Compression DeviceCOMPOSITE MANUFACTURING, INC.POY2021-04-16