Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal Cement Restrictor with Disposable Inserter and Small Cement Restrictor
Revolution - 0606705000
Device Description
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. 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: 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
Device IdentifiersDevice Id: 34546540912344
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04546540912343
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 04546540912343
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