Tube Sheath - MAJ-246
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
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 Identifiers
Device Id: 04953170032967
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
