NA TW31010

GUDID EPTWTW310100

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Ionization chamber radiation measuring probe

• Primary Device ID: EPTWTW310100
• NIH Device Record Key: 76d8c87a-328d-484f-9f7d-aef485bee9b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NA
• Version Model Number: Semiflex 0.125 cm³ ion chamber
• Catalog Number: TW31010
• 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	EPTWTW310100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972212

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, 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 [ NA]

• EPTWTW310100: Semiflex 0.125 cm³ ion chamber
• EPTWT410120: MP3-XS water tank