UNIDOS E T10008

GUDID EPTWT100080

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Radiation electrometer

• Primary Device ID: EPTWT100080
• NIH Device Record Key: 23d670c3-7970-47e2-9605-992c3b7a973c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIDOS E
• Version Model Number: UNIDOS E
• Catalog Number: T10008
• 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	EPTWT100080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951764

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 [UNIDOS E]

• EPTWT100100: UNIDOS E
• EPTWT100090: UNIDOS E
• EPTWT100080: UNIDOS E