Main-AXS Needle-Spinal Simplicity

Basic Information

• Brand Name: Main-AXS Needle-Spinal Simplicity
• Primary DI: B908350008000
• Version / Model: 292-11-920
• Catalog Number: 35-0008-000
• Company Name: Mainstream Medical Devices, LLC
• Labeler DUNS: 071513432
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-03
• Public Version: 1
• Public Version Date: 2024-12-11
• Public Version Status: New
• Public Device Record Key: 70aa151e-7da8-4b66-b549-86ef47a90af2

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58031	Bone access channel kit	A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B908350008000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Needle Gauge	11	Gauge
Length	6	Inch