T41022.1.021

GUDID EPTWT41022Q1Q0210

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, test object

• Primary Device ID: EPTWT41022Q1Q0210
• NIH Device Record Key: 1ff9bf37-ab45-490c-8d6c-e49e80884213
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MP3-M positioning device, rotatable
• Catalog Number: T41022.1.021
• 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	EPTWT41022Q1Q0210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954165

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

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• EPTWS1000090 - NA: 2018-07-06
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