AccessGUDID - DEVICE: Sectra Calibration Unit (07350092810395)

GUDID

Device Identifier (DI) Information

Brand Name: Sectra Calibration Unit
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sectra AB

Primary DI Number: 07350092810395
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354117848 *Terms of Use

Device Description: The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition. The calibration markers will be visible on the x-ray images and are intended to serve as scaling references. Typical users of the device are trained professionals, for example radiology technicians.

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?
40614	General-purpose diagnostic x-ray phantom, test object	A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both calibration protocols and in subjective and quantitative evaluations of various calibration and performance characteristics of conventional and digital general-purpose x-ray imaging systems. It is also used in the assessment of the performance characteristics of associated image acquisition, display, and analysis computer programs.	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: 280e427c-bbba-44bf-9567-c663f49090af
Public Version Date: November 15, 2022
Public Version Number: 1
DI Record Publish Date: November 07, 2022