OCTAVIUS T10057

GUDID EPTWT100570

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic

• Primary Device ID: EPTWT100570
• NIH Device Record Key: 2b6222d8-8a44-4797-8008-3ca419f1a4ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCTAVIUS
• Version Model Number: OCTAVIUS Detector 1600 MR
• Catalog Number: T10057
• Company DUNS: 318749751
• Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	EPTWT100570 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-07
• Device Publish Date: 2023-11-29

On-Brand Devices [OCTAVIUS]

• EPTWT430360: lnclinometer wireless
• EPTWT400630: OCTAVIUS Rotation Unit Modular
• EPTWT400580: OCTAVIUS Control Unit
• EPTWT400560: OCTAVIUS Rotation Unit
• EPTWT160390: DETECTOR INTERFACE 4000
• EPTWT100510: OCTAVIUS Detector 1500 xdr
• EPTWT100500: OCTAVIUS Detector 1500 MR
• EPTWT100440: OCTAVIUS Detector 1500
• EPTWT100420: OCTAVIUS Detector 729 XDR
• EPTWT100400: OCTAVIUS Detector 729
• EPTWT100360: OCTAVIUS Detector 1000 SRS
• EPTWT100580: OCTAVIUS Detector 1600 XDR
• EPTWT100570: OCTAVIUS Detector 1600 MR
• EPTWT100560: OCTAVIUS Detector 1600 SRS