JAM SHIDI
XIA PRECISION SYSTEM - 48237135
Device Description
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 5.0 Inch
- Diameter: 0.1 Inch
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LXH
Device Name: Orthopedic Manual Surgical Instrument
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OR
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: 888.4540
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 37613327277174
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327277173
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327277173
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