SDX System SDX0340V3.0

GUDID 03615070000606

SDX Trolley

DYN'R

Real-time position management respiratory gating system, spirometry
Primary Device ID03615070000606
NIH Device Record Key2eafb6e8-cc50-4fe2-b459-b1ed4a6c05ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameSDX System
Version Model Number3.0
Catalog NumberSDX0340V3.0
Company DUNS380807099
Company NameDYN'R
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com
Phone+33442210734
Emaildynr@dynr.com
Phone+0133442210734
Emaildynr@dynr.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103615070000606 [Previous]
GS103760290230026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-11
Device Publish Date2018-10-30