LA3-16AD

GUDID 08806167766030

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID08806167766030
NIH Device Record Keyadb1480b-9881-40ff-9fd6-826af38958a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLA3-16AD
Version Model NumberLA3-16AD
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
GS108806167766030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-09-11
Device Publish Date2025-09-03

On-Brand Devices [LA3-16AD]

08809702985668USP-L03GN4B/WR
08806167766030LA3-16AD

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