Magnifico Open

GUDID 08056304454737

ESAOTE SPA

Extremity MRI system, permanent magnet
Primary Device ID08056304454737
NIH Device Record Keya095b550-acc9-4bbe-89f5-21bf6d023623
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagnifico Open
Version Model Number100009900
Company DUNS437384304
Company NameESAOTE SPA
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304454737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-01
Device Publish Date2022-02-21

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08056304450869 - MyLab25 Gold2024-11-25
08056304451880 - PA121E2024-11-25
08056304452191 - TE122 2024-11-25 correct brand name is TEE122 with two E
08056304453419 - MyLabX82024-11-25
08056304454126 - MyLabX8 eXP2024-11-25
08056304455727 - G-scan Open2024-07-10
08056304455741 - O-scan Smart2024-07-10

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