FDA.reportPublic FDA data

SL1543

Primary DI
08056304450050
Brand
SL1543
Company
Esaote Europe B.V.
Model
122001200
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056304450050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056304450050080563044500508056304450050

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Regulatory Flags#

DUNS number
404392797
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056304453013MyLabOne1028100192017-02-24
08056304453020MyLabSix 1026420012017-02-24
08056304450043MyLabSat USA1028100182016-09-27
08056304450227MyLabFive4114102016-09-27
08056304450241MyLabFive BASIC UNIT4117762016-09-27
08056304450388MyLab40 eHD1022760002016-09-27
08056304450395MyLab401022760012016-09-27
08056304450401MyLab20 Plus1022760022016-09-27
08056304450425MyLab40 Basic Unit1022760042016-09-27
08056304450432MyLabSix1026420002016-09-27
08056304450470MyLabOne reg. Anestesia1028100122016-09-27
08056304450487MyLabSat1028100132016-09-27
08056304450494MyLabOne Musculoskeletal1028100142016-09-27
08056304450500MyLabOne Vascular1028100152016-09-27
08056304450517MyLabOne reg. Anestesia USA1028100162016-09-27
08056304450531MyLabTouch1028100202016-09-27
08056304450548MyLabOne Musculoskeletal USA1028100212016-09-27
08056304450555MyLabOne Vascular USA1028100222016-09-27
08056304450562MyLabTouch USA1028100232016-09-27
08056304450593Main Unit MyLabOne Double battery1028100912016-09-27

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08056304455635MyLabE80ESAOTE SPAITX2025-07-07
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