AVAmax PLUS Bone Cement Delivery System
AVAmax - VMX00CT
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
- Flash Point 50°F (10°C). Keep away from heat, sparks, open flame, and other sources of ignition. Store in a dark, dry place below 77°F (25°C) and protect from light.
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NDN
Device Name: Cement, Bone, Vertebroplasty
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 IdentifiersDevice Id: 10885403002113
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
Device Id: 50885403002111
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403002113
Package Quantity: 5
Package Discontinue Date: 4/13/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case