Sonoma Orthopedic Products, Inc

Basic Information

• Brand Name: Sonoma Orthopedic Products, Inc
• Primary DI: 00816988012115
• Version / Model: MINI-CRX®3.2x90mm
• Catalog Number: FST-32090
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-19
• Public Version: 5
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 8a4e0e65-0cdc-4c48-aff9-b0f926a933ce
• Distribution End Date: 2020-07-07

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46865	Clavicle intramedullary nail-like rod	A rod intended to be implanted into the intramedullary canal of the clavicle bone for the fixation of a fracture(s) and/or treatment of malunion(s)/nonunion(s). Also referred to as a nail or pin, it may be straight, curved or bendable, and might be partially-threaded, stabilised with a bone screw, and/or incorporate expandable hook-like features for stabilisation; it is typically made of stainless steel. Devices intended to assist with stabilisation (e.g., a bone screw) may be included with the rod. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816988012115	GS1