Faxitron

Basic Information

• Brand Name: Faxitron
• Primary DI: 00857069006005
• Version / Model: CoreVision 5x10
• Company Name: FAXITRON BIOPTICS, LLC
• Labeler DUNS: 968877360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 10cd2280-7955-4390-beda-b4f557cae82e

Device Description

Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Core Biopsy excisions.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MWP	Cabinet,X-Ray System	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42282	Stationary specimen x-ray system, digital	A stationary specimen x-ray system designed for permanent fixture in one location to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples (e.g., stereotactic biopsy cores taken during mammographic procedures) or amputated body parts. The data is either from analogue imaging and digitized afterwards or by digital imaging.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857069006005	GS1

Premarket Submissions

Submission Number	Supplement Number
K082432	000