- Physicians Office Resource

Precision System without Needle
PCD - 0506486000

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: JDZ

Device Name: Mixer, Cement, For Clinical Use

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: 888.4210

Third Party Flag: N

Medical Specialty: OR

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: 34546540518096

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04546540518095

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 04546540518095

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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