NA - AG-5591-01
Device Description
A device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). 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: ODC
Device Name: Endoscope Channel Accessory
Device Class: 2
Physical State: may include: biopsy cover, biopsy cap, external accessory channel, anti splatter device, locking device,
Definition: To give the endoscope channel additional or improved functionality.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: attach to endoscope channel
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: endoscope channel
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 16959664913496
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 06959664913499
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: box
Device Id: 06959664913499
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: 26959664913493
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 16959664913496
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: carton
