SonoSync

GUDID 08809944935018

SAMSUNG MEDISON CO., LTD.

Ultrasound imaging system workstation
Primary Device ID08809944935018
NIH Device Record Key5b4a2eac-86b0-4e31-b2e0-76b4d8f7454e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSync
Version Model NumberUSO-SYCPK10/SW
Company DUNS687785691
Company NameSAMSUNG MEDISON CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809944935018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-05
Device Publish Date2024-08-28

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

08809944906377 - CMV1-10Z2024-10-24
08809944906438 - CMV1-102024-10-24
08809944906872 - HERA Z202024-10-24
08809944935018 - SonoSync2024-09-05
08809944935018 - SonoSync2024-09-05
08809944884750 - TA2-92024-07-04
08809944885757 - RS85 Diagnostic Ultrasound System2024-06-25
08809944885801 - RS85 Diagnostic Ultrasound System2024-06-25
08809944885979 - RS85 Diagnostic Ultrasound System2024-06-25

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