CANNULA - PR-2B-1
Device Description
A flexible tube designed to be introduced into the tracheobronchial tree for the injection of contrast medium. It typically consists of a single lumen and an irrigation port, and is introduced via the oral cavity with a flexible endoscope. 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: 14953170043175
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170043178
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: 04953170043178
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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