5MHz CW

GUDID 08056304451859

ESAOTE SPA

Noninvasive vascular ultrasound system probe
Primary Device ID08056304451859
NIH Device Record Keyfb5e0928-db7a-4f56-8ac4-f36205cd34f9
Commercial Distribution StatusIn Commercial Distribution
Brand Name5MHz CW
Version Model Number9600126000
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
GS108056304451859 [Primary]

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 Number3
Public Version Date2023-11-03
Device Publish Date2016-09-27

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

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