YSIO X.pree

GUDID 04056869232904

Siemens Healthcare GmbH

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital
Primary Device ID04056869232904
NIH Device Record Keyc3b6e19d-1043-412d-a150-f226e62d3ed1
Commercial Distribution StatusIn Commercial Distribution
Brand NameYSIO X.pree
Version Model Number11107464
Company DUNS313217003
Company NameSiemens Healthcare GmbH
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX

Device Identifiers

Device Issuing AgencyDevice ID
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]
GS104056869232904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary
KPRSystem, x-ray, stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

Devices Manufactured by Siemens Healthcare GmbH

04056869232904 - YSIO X.pree2020-11-09
04056869232904 - YSIO X.pree2020-11-09
04056869269931 - LUMINOS Lotus Max2020-11-09
04056869272313 - syngo Dynamics2020-11-06 syngo Dynamics VA20I Packaging Label
04056869272320 - syngo Dynamics2020-11-06 syngo Dynamics VA20I Medical Device Identifier
04056869259802 - syngo.via2020-10-08 syngo.via VB50A Medical Device Identifier
04056869051291 - SOMATOM go.Now2020-09-07
04056869051314 - SOMATOM go.Up2020-09-07
04056869151564 - SOMATOM go.All2020-09-07

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