- Physicians Office Resource

Precision System with Needle/Radiopaque Bone Cement
PCD SpinePlex - 0505582000

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

Storage Environment Temperature - Degrees Celsius

25.00
0.00

Device Sizes

Needle Gauge: 10.0 Gauge

Needle Gauge: 10.0 Gauge

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LOD

Device Name: Bone Cement

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: Y

Target Area: N/A

Regulation Number: 888.3027

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 34546540434372

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04546540434371

Package Quantity: 4

Package Discontinue Date: 7/8/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: pack

Device Id: 04546540434371

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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