EndoSound® Ultrasound Disposable Kit (UDK-T) 5010

Basic Information

• Brand Name: EndoSound® Ultrasound Disposable Kit (UDK-T) 5010
• Primary DI: 00850050934097
• Version / Model: 5010
• Catalog Number: 5009
• Company Name: Endosound, Inc.
• Labeler DUNS: 111281644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-30
• Public Version: 1
• Public Version Date: 2024-02-07
• Public Version Status: New
• Public Device Record Key: 49c59438-1684-4898-aebe-a0eafc653bb2

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. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40761	General-purpose ultrasound imaging system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850050934097	GS1
Package	00850050934059	GS1	box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K232518	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	9.5	Millimeter
Device Size Text, specify			1.25mm wall thickness

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 75 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 75 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius