Main-AXS Needle-Spinal Simplicity 35-0009-000

GUDID B908350009000

Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula

Mainstream Medical Devices, LLC

Bone access channel kit

• Primary Device ID: B908350009000
• NIH Device Record Key: dcded93f-abf7-4be5-a952-5de813cef7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Main-AXS Needle-Spinal Simplicity
• Version Model Number: 299-08-900
• Catalog Number: 35-0009-000
• Company DUNS: 071513432
• Company Name: Mainstream Medical Devices, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com

Device Dimensions

• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch
• Needle Gauge: 8 Gauge
• Length: 7 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B908350009000 [Primary]

FDA Product Code

• OCJ: Spinal Channeling Instrument, Vertebroplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [Main-AXS Needle-Spinal Simplicity]

• B908350009000: Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula
• B908350008000: Single Use, Bone Access Needle, Sterile Blunt Stylus & Blunt Cannula with Extra Trocar Stylus