ULTRASONIC PROBE

ULTRASONIC PROBE - UM-DP20-25R

A flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.

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Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• High-level Disinfectant
• Ethylene Oxide

Code: FET

Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Device Class: 2

Physical State: May include: ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.

Definition: To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted through endoscope.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in gi and gu tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: ODG

Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology

Device Class: 2

Physical State: ultrasound system and system accessories, endoscope

Definition: To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses ultrasound to visualize body cavities through endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170368448

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