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NA - AG-5062-N2024G

A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

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No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LQR

Device Name: Dislodger, Stone, Biliary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5010

Third Party Flag: Y

Medical Specialty: GU

Device Id: 16959664900762

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 06959664900765

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: box

Device Id: 06959664900765

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: 26959664900769

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 16959664900762

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: carton