AccessGUDID - DEVICE: Xpress BCD LLC (00860008878335)

GUDID

Device Identifier (DI) Information

Brand Name: Xpress BCD LLC
Version or Model: Inner Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xpress Bcd LLC

Primary DI Number: 00860008878335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047751363 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POY	Post Breast Biopsy Hemostatic Breast Compression Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163388	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a16f3bb-958d-4052-ab69-3fc2f287c47f
Public Version Date: May 15, 2023
Public Version Number: 1
DI Record Publish Date: May 05, 2023