GUDID 00195278117021

SIGNA Artist System Medical Device Assembly-MDR

GE Medical Systems (Tianjin) Co., Ltd.

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Primary Device ID00195278117021
NIH Device Record Key7c06694c-1dee-4a2a-83f4-ac99999bd572
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSIGNA Artist
Company DUNS421356265
Company NameGE Medical Systems (Tianjin) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
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
GS100195278117021 [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 Date2021-01-20
Device Publish Date2021-01-12

Devices Manufactured by GE Medical Systems (Tianjin) Co., Ltd.

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00195278372307 - NA2021-06-23 Voyager AIR Medical Device Assembly
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00195278124609 - NA2021-02-10 Kizuna System Medical Device Assembly-MDR

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