- Physicians Office Resource

SINGLE USE CANNULA
SINGLE USE CANNULA - PR-427Q

Device Description

A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: ODD

Device Name: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Device Class: 2

Physical State: catheter. may include radiopaque markings

Definition: To identify stones, tumors, or narrowing in the biliary tree.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Passed through an endoscope (duodenoscope) into the biliary duct to inject x-ray contract media into the biliary tree.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: biliary tree

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 14953170154734

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170154737

Package Quantity: 6

Package Discontinue Date: 8/12/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170154737

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

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