Built-up set of 5 caps for PFD and EFD 3G-pSi field detectors

Basic Information

• Brand Name: Built-up set of 5 caps for PFD and EFD 3G-pSi field detectors
• Primary DI: EIBA7354910
• Version / Model: 735491
• Company Name: IBA Dosimetry GmbH
• Labeler DUNS: 332599307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a3b0528d-2c72-4134-86b4-040c22474d71

Device Description

Set of 5 brass built-up caps for PFD and EFD 3G-pSi field detectors for in-air measurements for Helax TMS, Elekta Renderplan/ Preciseplan and Nucletron Oncentra Masterplan

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	EIBA7354910	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]