MyLabX9

GUDID 08056304454676

ESAOTE SPA

General-purpose ultrasound imaging system
Primary Device ID08056304454676
NIH Device Record Key8fc6e377-2686-4903-89c4-834e60f16e44
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyLabX9
Version Model Number100644015
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
GS108056304454676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by ESAOTE SPA

08056304455727 - G-scan Open2024-07-10
08056304455741 - O-scan Smart2024-07-10
08056304455628 - MyLabE802024-04-08
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.