EV2-12

GUDID 08800290027471

SAMSUNG MEDISON CO., LTD.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID08800290027471
NIH Device Record Key36cab1ef-df0b-45f4-869d-6d716a9521ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameEV2-12
Version Model NumberUSP-VN2CF1A/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
GS108800290027471 [Primary]

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

On-Brand Devices [EV2-12]

08809880020021USP-VF2CF1A/WR
08800290042542USP-VN2CFFA/WR
08800290065473USP-VF2CFFA/WR
08800290027471USP-VN2CF1A/WR

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