AccessGUDID - DEVICE: Xact (00854623006143)

GUDID

Device Identifier (DI) Information

Brand Name: Xact
Version or Model: M10AC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M10AC
Company Name: Solstice Corporation

Primary DI Number: 00854623006143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 609823877 *Terms of Use

Device Description: Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosynthesis-area-of-concern-markers/

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
40805	Radiographic image marker, manual	An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.	Active	false
47020	Imaging lesion localization marker, external, single-use	A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAC	System, X-Ray, Film Marking, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f6d5753-8e3f-4887-9d2c-d511bb58cb80
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 26, 2021