FDA.reportPublic FDA data

EndoSound® EVS™ Bands

Primary DI
00850050934141
Brand
EndoSound® EVS™ Bands
Company
Endosound, Inc.
Model
18102
Catalog number
5013
Device description
EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes.
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

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
00850050934158PackageGS110In Commercial Distribution
10850050934155PackageGS110In Commercial Distribution
00850050934141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934158008500509341588500509341580850050934158
1085005093415510850050934155
00850050934141008500509341418500509341410850050934141

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter9.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
111281644
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050934288EndoSound® EVS™ SideKick 5107510751072026-10-30
00850050934196EndoSound® Biopsy Port Adapter 5054505450542026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064506450642026-06-01
00850050934233EndoSound® EVS Probe510151012026-06-01
00850050934240EndoSound® EVS SideBeam 5103510351032026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)510451042026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)510551052026-06-01
00850050934165EndoSound® Ultrasound Transducer Module (UTM)501650162024-10-31
00850050934189EndoSound® EVS™ Band Applicator501250122024-08-30
10850050934186EndoSound® EVS™ Band Applicator501250122024-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06903053064064Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
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