Roos TM34001

GUDID EPTWTM340010

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Ionization chamber radiation measuring probe

• Primary Device ID: EPTWTM340010
• NIH Device Record Key: 5f5e0f1a-45fe-411e-8c2a-d31bdcc9ce59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Roos
• Version Model Number: Roos electron chamber 0.35 cm³
• Catalog Number: TM34001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPTWTM340010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961208

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: 2017-04-27

On-Brand Devices [Roos]

• EPTWTW340010: Roos electron chamber 0.35 cm³
• EPTWTN340010: Roos electron chamber 0.35 cm³
• EPTWTM340010: Roos electron chamber 0.35 cm³
• EPTWTB340010: Roos electron chamber 0.35 cm³