- Physicians Office Resource

Single Use Retrieval Nitinol Basket V - FG-V451P

Device Description

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.

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: 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

Code: OCZ

Device Name: Endoscopic Grasping/Cutting Instrument, Non-Powered

Device Class: 2

Physical State: Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger

Definition: To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Place through an endoscope to reach desired area.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various tissues, stones or other foreign bodies within GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Identifiers

Device Id: 14953170395328

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170395321

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170395321

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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