DAVID T34065

GUDID EPTWT340650

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic

• Primary Device ID: EPTWT340650
• NIH Device Record Key: fabe9d13-c433-475c-a79f-dc7897f805e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAVID
• Version Model Number: DAVID Elekta MLC-80
• Catalog Number: T34065
• Company DUNS: 318749751
• Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau 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: 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
HIBCC	EPTWT340650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062817

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2017-04-26

On-Brand Devices [DAVID]

• EPTWT340850: DAVID Elekta MLC-160
• EPTWT340840: DAVID Siemens MLC-160
• EPTWT340790: DAVID Varian MLC-80
• EPTWT340770: DAVID Varian MLC-120
• EPTWT340650: DAVID Elekta MLC-80
• EPTWT340640: DAVID Siemens MLC-58