8GAX10CM TEN CANNULAE PACK
HYDROSET - 707001
Device Description
A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
Environmental Conditions
No Data Available
Device Sizes
- Length: 10.0 Centimeter
- Needle Gauge: 8.0 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GEA
Device Name: Cannula, Surgical, General & Plastic Surgery
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
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: 878.4800
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 07613154804788
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: 37613154804789
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613154804788
Package Quantity: 10
Package Discontinue Date: 10/18/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: pack