EV3-10T

GUDID 08800013513083

ALPINION MEDICAL SYSTEMS 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 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 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 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 ID08800013513083
NIH Device Record Keyea697d96-2533-4f0b-bed0-4ae5a7eb2f5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEV3-10T
Version Model NumberEV3-10T
Company DUNS557800655
Company NameALPINION MEDICAL SYSTEMS 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800013513083 [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 Number6
Public Version Date2022-11-02
Device Publish Date2016-09-23

Devices Manufactured by ALPINION MEDICAL SYSTEMS CO.,LTD

08800013510037 - L3-12HWD2022-11-02
08800013510075 - L3-12X2022-11-02
08800013510150 - L3-8H2022-11-02
08800013512093 - P1-5CT2022-11-02
08800013513076 - EC3-10T2022-11-02
08800013513083 - EV3-10T2022-11-02
08800013513083 - EV3-10T2022-11-02
08800013515001 - VE3-10H2022-11-02
08800013519016 - CW5.02022-11-02
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