FDA.report

EndoSound® Ultrasound Disposable Kit (UDK-T) 5006

Primary DI
00850050934080
Brand
EndoSound® Ultrasound Disposable Kit (UDK-T) 5006
Company
Endosound, Inc.
Model
5006
Catalog number
5005
Device description
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Published
2024-01-30
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
00850050934073PackageGS110In Commercial Distribution
00850050934080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050934073008500509340738500509340730850050934073
00850050934080008500509340808500509340800850050934080

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 Diameter9Millimeter

Storage And Handling

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
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
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
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 DIBrandCompanyProduct codePublished
16932503534700Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534724Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534731Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534748Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534779Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534786Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534816Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534823Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534861Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534885Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
84961333253902PENTAXHOYA CORPORATIONODG2025-04-04
84961333253933PENTAXHOYA CORPORATIONODG2025-04-04
84961333253957PENTAXHOYA CORPORATIONODG2025-04-04
84953170463927BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.ODG2025-02-25
00827002609921EchoTip ClearCoreCOOK IRELAND LTDODG2025-01-14
10850050934186EndoSound® EVS™ Band ApplicatorEndosound, Inc.ODG2024-08-30
00850050934141EndoSound® EVS™ BandsEndosound, Inc.ODG2024-06-14
00191506030766Acquire™ SBOSTON SCIENTIFIC CORPORATIONODG2024-05-16
00191506030773Acquire™ SBOSTON SCIENTIFIC CORPORATIONODG2024-05-15
06945868603472SonoScapeSONOSCAPE MEDICAL CORP.ODG2024-03-30
00850050934011EndoSound® Transducer Extension Connector (TEC)Endosound, Inc.ODG2024-01-30
00850050934028EndoSound® EVSScannerEndosound, Inc.ODG2024-01-30
00850050934042EndoSound® Ultrasound Disposable Kit (UDK-T) 5004Endosound, Inc.ODG2024-01-30
00850050934097EndoSound® Ultrasound Disposable Kit (UDK-T) 5010Endosound, Inc.ODG2024-01-30
00850050934103EndoSound® Ultrasound Disposable Kit (UDK-T) 5008Endosound, Inc.ODG2024-01-30
00850050934127EndoSound® Vision System (EVS) SoftwareEndosound, Inc.ODG2024-01-30
00827002597464EchoTip AcuCoreCOOK IRELAND LTDODG2023-10-03
04961333239382PENTAXHOYA CORPORATIONODG2023-07-31
84961333253926PENTAXHOYA CORPORATIONODG2023-07-31
16932503534632MTMicro-Tech (Nanjing) Co., Ltd.ODG2023-06-28