NA

NA - AG-5041-3526

A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. 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: OCY

Device Name: Endoscopic Guidewire, Gastroenterology-Urology

Device Class: 2

Physical State: metal guidewire with or without polymer coating, and associated guidewire accessories

Definition: To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: placed through working channel of endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 16959664900021

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 06959664900024

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: box

Device Id: 06959664900024

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: 26959664900028

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 16959664900021

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: carton