FDA.report

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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K232518000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850050934158PackageGS110In Commercial Distribution
10850050934155PackageGS110In Commercial Distribution
00850050934141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934158008500509341588500509341580850050934158
1085005093415510850050934155
00850050934141008500509341418500509341410850050934141

GMDN Terms

TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter9.5Millimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide

Contacts

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850050934165EndoSound® Ultrasound Transducer Module (UTM)501650162024-10-31
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

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