HM70 EVO

GUDID 08809725818530

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system
Primary Device ID08809725818530
NIH Device Record Key206392c6-1f04-4541-af19-9deee1c8d5ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameHM70 EVO
Version Model NumberUSS-M7EPC1B/US
Company DUNS687785691
Company NameSAMSUNG MEDISON CO., LTD.
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 Datefalse
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
GS108809725818530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-01
Device Publish Date2022-05-24

On-Brand Devices [HM70 EVO]

08809725794100USS-M7EPC30/US
08809725793424USS-M7EPF30/US
08809725793240USS-M7EPF30/US
08809725793066USS-M7EPCC0/US
08809725792960USS-M7ENF30/US
08809725792786USS-M7ENCC0/US
08809725792601USS-M7ENC30/US
08809725792342USS-M7ENNC0/US
08809725792168USS-M7ENN30/US
08809725791987USS-M7ENLC0/US
08809725791802USS-M7ENL30/US
08809725791628USS-M7ENFC0/US
08809725791420USS-M7EPF10/US
08809725791246USS-M7EPC10/US
08809725791147USS-M7ENN10/US
08809725790966USS-M7ENL10/US
08809725790782USS-M7ENF10/US
08809725790607USS-M7ENC10/US
08809725819070USS-M7EPFCB/US
08809725818899USS-M7EPF1B/US
08809725818714USS-M7EPCCB/US
08809725818530USS-M7EPC1B/US
08809725818332USS-M7ENNCB/US
08809725818158USS-M7ENN1B/US
08809725817977USS-M7ENLCB/US
08809725817793USS-M7ENL1B/US
08809725817618USS-M7ENFCB/US
08809725817434USS-M7ENF1B/US
08809725817250USS-M7ENCCB/US
08809725817076USS-M7ENC1B/US
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