MyLabSigma

GUDID 08056304453679

ESAOTE SPA

General-purpose ultrasound imaging system
Primary Device ID08056304453679
NIH Device Record Key3e078599-0f97-4c02-893b-a9ff19143ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyLabSigma
Version Model Number101741004
Company DUNS437384304
Company NameESAOTE SPA
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304453679 [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 Date2019-06-21
Device Publish Date2019-06-13

Devices Manufactured by ESAOTE SPA

08056304454287 - PX 1-52023-12-22
08056304454614 - 2CWS-L2023-12-22
08056304454621 - 5CWS-L2023-12-22
08056304454812 - TE 3-82023-12-22
08056304454836 - CX 1-82023-12-22
08056304454935 - LMX 4-202023-12-22
08056304454980 - MyLabX902023-12-22
08056304455000 - LX 3-152023-12-22

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