Product Overview

BladderScan® - BVI 9400

Device Description

An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also referred to as a bladder, or urethra probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: ITX

Device Name: Transducer, Ultrasonic, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1570

Third Party Flag: Y

Medical Specialty: RA

Device Identifiers

Device Id: 10879123002973

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00879123002976

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00879123002976

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Educational Resources