SX-One MicroKnife

Basic Information

• Brand Name: SX-One MicroKnife
• Primary DI: 00860002094700
• Version / Model: 600112-001
• Catalog Number: 600112-001
• Company Name: SONEX HEALTH, INC.
• Labeler DUNS: 040211080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 3
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 90718478-d8fd-4996-9b90-d0de2b6a238e

Device Description

SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome. UltraGuideCTR is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58783	Hand ligament surgical release instrument	A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002094700	GS1
Package	00860002094717	GS1	Box	3	In Commercial Distribution

Customer Contacts

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