LUMINOS Lotus Max

GUDID 04056869269931

Siemens Healthcare GmbH

Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital
Primary Device ID04056869269931
NIH Device Record Key8907eed4-5da1-4c41-bfe9-3a019871f984
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUMINOS Lotus Max
Version Model Number11574100
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]
GS104056869269931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system
OWBInterventional fluoroscopic x-ray system

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
04056869269931 - LUMINOS Lotus Max2020-11-09
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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