AccessGUDID - DEVICE: SDX System (03760290230132)

GUDID

Device Identifier (DI) Information

Brand Name: SDX System
Version or Model: V1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SDX0361V1.0
Company Name: DYN'R

Primary DI Number: 03760290230132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 380807099 *Terms of Use
Previous DI: 03615070000408

Device Description: Gating Module for Siemens 4D-CT

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):	Yes
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?
62723	Real-time position management respiratory gating system, spirometry	An assembly of electronic devices designed to track the respiratory pattern of a patient by means of spirometry to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It tracks the patient’s respiration using a spirometer into which the patient breaths, providing real-time measurement of the respiratory cycle to enable irradiation control during the procedure, and may include visual feedback enabling the patient to manage their own voluntary breathing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHN	System, Radiation Therapy, Charged-Particle, Medical
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121845	000

Device Exempt from Premarket Submission: No 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: dbd3abd3-b851-4da5-b4ca-ef4fc2e9939d
Public Version Date: November 30, 2018
Public Version Number: 1
DI Record Publish Date: October 30, 2018