Percutaneous Cement Gun
NA - 0306650000
Device Description
A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable 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: 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: 04546540434340
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