C2-8

GUDID 08806167759933

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID08806167759933
NIH Device Record Key1cc3b758-97a4-4e85-820d-5307ad8ece6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2-8
Version Model NumberUSP-C028N6A/WR
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
GS108806167759933 [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 Date2020-05-06
Device Publish Date2020-04-28

On-Brand Devices [C2-8]

08806167759933USP-C028N6A/WR
08809702980571USP-C028N6B/WR

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