5CWL

GUDID 08056304455079

ESAOTE SPA

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID08056304455079
NIH Device Record Keye8406f12-8ef5-4d91-a1bc-54044c881a8e
Commercial Distribution StatusIn Commercial Distribution
Brand Name5CWL
Version Model Number120000107
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
GS108056304455079 [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 Date2025-07-15
Device Publish Date2025-07-07

Devices Manufactured by ESAOTE SPA

08056304455017 - MyLabA502025-07-15
08056304455062 - 2CWL2025-07-15
08056304455079 - 5CWL2025-07-15
08056304455079 - 5CWL2025-07-15
08056304455215 - MyLabE852025-07-15
08056304455222 - P 1-5E2025-07-15
08056304455239 - C 1-8E2025-07-15
08056304455307 - MyLabA702025-07-15
08056304455383 - L 3-15E2025-07-15

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