AccessGUDID - DEVICE: KermaX-plus (EIBA120131290)

GUDID

Device Identifier (DI) Information

Brand Name: KermaX-plus
Version or Model: 6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 120-131OEM CAN
Company Name: IBA Dosimetry GmbH

Primary DI Number: EIBA120131290
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332599307 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38385	Diagnostic x-ray system quality assurance device	An instrument intended to be used to assess the performance of diagnostic x-ray equipment for quality assurance (QA) purposes; it is typically intended to measure, display, and record one or more x-ray parameter(s) [e.g., kVp, mAs, dose, exposure time]. It may be placed in the field of view and/or be connected to the x-ray equipment, and may have various forms (e.g., handheld or desktop unit with sensor and dedicated software).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHO	Instrument, Quality-Assurance, Radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 078b9a8e-ff68-49b3-9d5d-702e6765dc2e
Public Version Date: July 04, 2022
Public Version Number: 2
DI Record Publish Date: December 17, 2021