FDA.reportPublic FDA data

EndoSound® Ultrasound Transducer Module (UTM)

Primary DI
00850050934165
Brand
EndoSound® Ultrasound Transducer Module (UTM)
Company
Endosound, Inc.
Model
5016
Catalog number
5016
Device description
EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Published
2024-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232518000EndoSound Vision System; EVSEndosound, Inc.2023-12-27ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050934165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934165008500509341658500509341650850050934165

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic ultrasound imaging transducerA flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure75 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(971) 231-4791info@endosound.com

Regulatory Flags#

DUNS number
111281644
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850050934186EndoSound® EVS™ Band Applicator501250122024-08-30
00850050934141EndoSound® EVS™ Bands1810250132024-06-14
00850050934011EndoSound® Transducer Extension Connector (TEC)500250022024-01-30
00850050934028EndoSound® EVSScanner500050002024-01-30
00850050934035EndoSound® Ultrasound Transducer Module (UTM)500150012024-01-30
00850050934042EndoSound® Ultrasound Disposable Kit (UDK-T) 5004500450032024-01-30
00850050934080EndoSound® Ultrasound Disposable Kit (UDK-T) 5006500650052024-01-30
00850050934097EndoSound® Ultrasound Disposable Kit (UDK-T) 5010501050092024-01-30
00850050934103EndoSound® Ultrasound Disposable Kit (UDK-T) 5008500850072024-01-30
00850050934110EndoSound® Air Leak Tester503050302024-01-30
00850050934127EndoSound® Vision System (EVS) Software501150112024-01-30

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Primary DI, Brand, Company table
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04987670102745LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
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04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
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