- Physicians Office Resource

Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Revision Cement Restrictor, Small and Universal Cement Restrictor
Revolution - 0606705000S1

Device Description

A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use 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 Identifiers

Device Id: 37613154354390

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613154354399

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613154354399

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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