HS50 / HS60 Diagnostic Ultrasound System

GUDID 08806167793883

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system
Primary Device ID08806167793883
NIH Device Record Keyfd11d9cb-77f7-45a9-8d59-b3c9103f0765
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS50 / HS60 Diagnostic Ultrasound System
Version Model NumberUSS-HS5NL3K/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
GS108806167793883 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-10
Device Publish Date2018-12-13

On-Brand Devices [HS50 / HS60 Diagnostic Ultrasound System]

08806167794828USS-HS6PF4K/US
08806167794637USS-HS6NL4K/US
08806167794453USS-HS5PF4K/US
08806167794262USS-HS5PF3K/US
08806167794071USS-HS5NL4K/US
08806167793883USS-HS5NL3K/US
08806167793333USS-HS6PB4K/US
08806167793142USS-HS6NB4K/US
08806167792954USS-HS5PB4K/US
08806167792763USS-HS5PB3K/US
08806167792572USS-HS5NB4K/US
08806167792381USS-HS5NB3K/US
08806167764548USS-HS6PF40/US
08809521028805USS-HS5PF3M/US
08809521028614USS-HS5PB3M/US
08809521028423USS-HS5NL3M/US
08809521028232USS-HS5NB3M/US
08809521028041USS-HS5PF4M/US
08809521027853USS-HS5PB4M/US
08809521027662USS-HS5NL4M/US
08809521027471USS-HS5NB4M/US
08809521027280USS-HS6PF4M/US
08809521027099USS-HS6PB4M/US
08809521026900USS-HS6NL4M/US
08809521026719USS-HS6NB4M/US
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