Faxitron

GUDID 00857069006005

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

FAXITRON BIOPTICS, LLC

Stationary specimen x-ray system, digital

• Primary Device ID: 00857069006005
• NIH Device Record Key: 10cd2280-7955-4390-beda-b4f557cae82e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faxitron
• Version Model Number: CoreVision 5x10
• Company DUNS: 968877360
• Company Name: FAXITRON BIOPTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857069006005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082432

FDA Product Code

• MWP: Cabinet,X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Faxitron]

• 00857069006227: Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional d
• 00857069006210: Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excision
• 00857069006203: Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of ha
• 00857069006197: Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of h
• 00857069006180: Stationary digital specimen x-ray system with 10x15 cm imager intended for the verification of h
• 00857069006050: Stationary digital specimen x-ray system with 23x29cm imager intended for the examination of Cor
• 00857069006043: Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excision
• 00857069006036: Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excision
• 00857069006029: Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisi
• 00857069006012: Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excision
• 00857069006005: Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Cor