BioJet Target

GUDID 04260476810015

Software for biopsy needle guide planning and tracking.

Medical Targeting Technologies GmbH

Brachytherapy system application software

• Primary Device ID: 04260476810015
• NIH Device Record Key: a0c5cc3b-8925-43f1-a021-9a4aba4951a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioJet Target
• Version Model Number: 3
• Company DUNS: 313263045
• Company Name: Medical Targeting Technologies GmbH
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +494133510185
• Email: peter.klews@dktech.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260476810015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122329

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2016-09-16