HS40

GUDID 08809725785962

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID08809725785962
NIH Device Record Key5aed705f-08bd-4759-8c16-daa3bf91105d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS40
Version Model NumberUSS-HS4NB3E/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
GS108809725785962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

08809725785962 - HS40 2021-06-10
08809725785962 - HS40 2021-06-10
08809725782350 - HS60 Diagnostic Ultrasound System2021-04-23 V2.03
08809725782732 - HS60 Diagnostic Ultrasound System2021-04-23 V2.03
08809725794568 - HS60 Diagnostic Ultrasound System2021-04-23
08809725794742 - HS60 Diagnostic Ultrasound System2021-04-23
08809725794926 - HS50 Diagnostic Ultrasound System2021-04-23 V2.03
08809725795107 - HS50 Diagnostic Ultrasound System2021-04-23 V2.03
08809725795282 - HS50 Diagnostic Ultrasound System2021-04-23 V2.03

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