V5-9

GUDID 08806167797829

SAMSUNG MEDISON CO., LTD.

Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer
Primary Device ID08806167797829
NIH Device Record Key92360c51-296d-41b2-ad9c-4b7d17d50e05
Commercial Distribution StatusIn Commercial Distribution
Brand NameV5-9
Version Model NumberUSP-RV059F0AWR
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
GS108806167797829 [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 Date2020-12-24
Device Publish Date2020-12-16

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

08809944879305 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944879480 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944879664 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944879848 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944880028 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944880202 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944880387 - HM70 EVO Diagnostic Ultrasound System2024-01-11
08809944880561 - HM70 EVO Diagnostic Ultrasound System2024-01-11

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