KermaX-plus 120-131RSZKO

GUDID EIBA120131RSZKO1

KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.

IBA Dosimetry GmbH

X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator X-ray system quality assurance device, x-ray tube simulator Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device Diagnostic x-ray system quality assurance device

• Primary Device ID: EIBA120131RSZKO1
• NIH Device Record Key: b9803bda-18d6-48ff-87b0-bed0fabc66d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KermaX-plus
• Version Model Number: 1
• Catalog Number: 120-131RSZKO
• Company DUNS: 332599307
• Company Name: IBA Dosimetry 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com
• Phone: +1 786 288 0369
• Email: service-usa@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBA120131RSZKO0 [Primary]
HIBCC	EIBA120131RSZKO1 [Package]; Contains: EIBA120131RSZKO0; Package: [1 Units]; In Commercial Distribution

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [KermaX-plus]

• EIBA1202101: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120206S1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA1202061: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120205TINO1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120205S1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA1202051: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120160MFD1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120160LFD1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120160EAS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120140XCAN1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120132MG1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA1201321: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131ZKCANTIN1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131ZKCAN1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131TINO1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131RSZKO1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131RSZKHS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131RSZK1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131P1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131OEMHS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131OEM1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131ISHS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131IS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131HSE1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131HS1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131ETH1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131E1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131CANTINO1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131AIR1: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131331: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131321: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131311: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131291: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131281: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131271: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131261: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131251: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131241: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131231: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131221: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131210: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131161: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131151: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131131: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131121: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120131111: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA12013041: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA12013031: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA12013020: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b
• EIBA120130101: KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to b