Faxitron OR

GUDID 00857069006265

FAXITRON BIOPTICS, LLC

Specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD

• Primary Device ID: 00857069006265
• NIH Device Record Key: 1c1e3229-44b7-41f5-9232-e95c69e26454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faxitron OR
• Version Model Number: BioVision 10x15
• 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	00857069006265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091558

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: 2020-01-22
• Device Publish Date: 2019-07-02

Devices Manufactured by FAXITRON BIOPTICS, LLC

• 00857069006265 - Faxitron OR: 2020-01-22
• 00857069006265 - Faxitron OR: 2020-01-22
• 00857069006012 - Faxitron: 2020-01-22 Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excisions.
• 00857069006029 - Faxitron: 2020-01-22 Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisions.
• 00857069006036 - Faxitron: 2020-01-22 Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excisions.
• 00857069006043 - Faxitron: 2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions.
• 00857069006210 - Faxitron: 2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions.
• 00857069006272 - Faxitron Core: 2019-07-10
• 00857069006289 - Faxitron Path: 2019-07-10