NA

NA - AG-5591-01

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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