G-scan Open

GUDID 08056304455727

ESAOTE SPA

Extremity MRI system, permanent magnet
Primary Device ID08056304455727
NIH Device Record Key06070107-ef68-4706-bee5-471232cebe47
Commercial Distribution StatusIn Commercial Distribution
Brand NameG-scan Open
Version Model Number100001700
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
GS108056304455727 [Primary]

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-10
Device Publish Date2024-07-02

Devices Manufactured by ESAOTE SPA

08056304455727 - G-scan Open2024-07-10
08056304455727 - G-scan Open2024-07-10
08056304455741 - O-scan Smart2024-07-10
08056304455628 - MyLabE802024-04-08
08056304454287 - PX 1-52023-12-22
08056304454614 - 2CWS-L2023-12-22
08056304454621 - 5CWS-L2023-12-22
08056304454812 - TE 3-82023-12-22
08056304454836 - CX 1-82023-12-22

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