Cartridge
VertePort X4 Manifold - 0605411500
Device Description
A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Needle Gauge: 11.0 Gauge
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: 37613252648643
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613252648642
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613252648642
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
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