Precision System Kit with Short Extension Tube
PCD - 0506489000
Device Description
A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable 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: OAR
Device Name: Injector, Vertebroplasty (Does Not Contain Cement)
Device Class: 1
Physical State: plastic syringe type device -- some embodiments may include levers or screws to increase injection force or control
Definition: Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Submission Type ID: 4
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses mechanical force to inject bone cement into vertebra
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: vertebra
Regulation Number: 888.4200
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 34546540907074
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04546540907073
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 04546540907073
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