UNIDOS

Basic Information

• Brand Name: UNIDOS
• Primary DI: EPTWTN100520
• Version / Model: UNIDOS Tango
• Catalog Number: TN10052
• Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
• Labeler DUNS: 318749751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-14
• Public Version: 1
• Public Version Date: 2026-04-22
• Public Version Status: New
• Public Device Record Key: a133a117-c42e-42e4-9f47-e3b2b22ed8e4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36596	Radiation electrometer	A stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EPTWTN100520	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K951764	000