CANNULA - PR-113Q-1
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 reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
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 IdentifiersDevice Id: 14953170043847
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170043840
Package Quantity: 1
Package Discontinue Date: 8/12/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 04953170043840
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
Device Id: 84953170043846
Device Type: Unit of Use
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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