CMV1-10

GUDID 08809944906438

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID08809944906438
NIH Device Record Keyeaf8edf7-d86e-4834-93da-c0448d490b7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCMV1-10
Version Model NumberUSP-V01AFBA/WR
Company DUNS687785691
Company NameSAMSUNG MEDISON CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS108809944906438 [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 Date2024-10-24
Device Publish Date2024-10-16

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

08809944937180 - HERA W10 Diagnostic Ultrasound System2024-12-16
08809944937371 - HERA W10 Diagnostic Ultrasound System2024-12-16
08809944937555 - HERA W9 Diagnostic Ultrasound System2024-12-16
08809944937746 - HERA W9 Diagnostic Ultrasound System2024-12-16
08809944937913 - HERA W9 Diagnostic Ultrasound System2024-12-16
08809944938088 - HERA W9 Diagnostic Ultrasound System2024-12-16
08809944938118 - HERA W10 Diagnostic Ultrasound System2024-12-16
08809944938262 - HERA W10 Diagnostic Ultrasound System2024-12-16

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