DISPOSABLE MECHANICAL LITHOTRIPTOR

DISPOSABLE MECHANICAL LITHOTRIPTOR
DISPOSABLE MECHANICAL LITHOTRIPTOR - BML-201Q

A manual instrument designed to be inserted through the working channel of an endoscope to trap and fragment/crush biliary stones in situ for the treatment of conditions such as cholelithiasis. It typically consists of a flexible sheath with a braided self-expanding grasping mechanism at the distal end, which has the ability to contract around and fragment stones; it may incorporate a handle and/or be attached to an independent handle. The device is typically used in association with procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic cholecystectomy. 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: LQC

Device Name: Lithotriptor, Biliary Mechanical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 876.4500

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170033077

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170033070

Package Quantity: 1

Package Discontinue Date: 8/9/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170033070

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