Medistim Doppler probe PD110752

GUDID 07070554100740

Medistim ASA

Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe
Primary Device ID07070554100740
NIH Device Record Keyb5c320db-f948-4783-8225-17bdcb767a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedistim Doppler probe
Version Model NumberPD110752
Catalog NumberPD110752
Company DUNS519521751
Company NameMedistim ASA
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107070554100740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-20
Device Publish Date2016-09-15

Devices Manufactured by Medistim ASA

07070554103444 - Medistim MiraQ Vascular System2024-04-22
07070554104854 - Medistim System Activation Card2021-10-19
07070554104861 - Medistim System Activation Card2021-10-19
07070554104878 - Medistim System Activation Card2021-10-19
07070554104885 - Medistim System Activation Card2021-10-19
07070554104489 - Medistim Interconnect Cable2020-11-09
07070554104502 - Medistim Interconnect Cable2020-11-09
07070554104519 - Medistim Interconnect Cable2020-11-09

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