AccessGUDID - DEVICE: Xpress BCD Breast Compression Device (00810105030501)

GUDID

Device Identifier (DI) Information

Brand Name: Xpress BCD Breast Compression Device
Version or Model: BCD-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPOSITE MANUFACTURING, INC.

Primary DI Number: 00810105030501
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947090650 *Terms of Use

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

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?
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.	Obsolete	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 [?]
Premarket Submission Number Not Available/Not Released

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: a7c80012-b762-460a-8ef7-75ab81f23644
Public Version Date: April 26, 2021
Public Version Number: 1
DI Record Publish Date: April 16, 2021