HERA W9, HERA W10 Diagnostic Ultrasound System

GUDID 08809880032949

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
Primary Device ID08809880032949
NIH Device Record Key7eb31aae-a6f2-46a1-897b-1f9b6a5f0a96
Commercial Distribution StatusIn Commercial Distribution
Brand NameHERA W9, HERA W10 Diagnostic Ultrasound System
Version Model NumberUSS-HRW1F4D/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
GS108809880032949 [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 Date2023-05-03
Device Publish Date2023-04-25

On-Brand Devices [HERA W9, HERA W10 Diagnostic Ultrasound System]

08809880049220USS-HRW9R3D/US
08809880049084USS-HRW9R4D/US
08809880044485USS-HW1ER4D/US
08809880033519USS-HRW9F3D/US
08809880033274USS-HRW9F4D/US
08809880032949USS-HRW1F4D/US
08809880032734USS-HRW1R4D/US

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.