SX-One MicroKnife

FDA UDI

Class I (US FDA UDI)

by SONEX HEALTH, Inc

Identity

Trade Name: SX-One MicroKnife FDA UDI
Generic Name: Hand ligament surgical release instrument FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 600112-001 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 600112-001 FDA UDI
Primary DI / UDI-DI: 00860002094700 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Hand ligament surgical release instrument FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Hand ligament surgical release instrument

SX-One MicroKnife by SONEX HEALTH, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: SONEX HEALTH, Inc

Sources (1)

FDA UDI 90718478-d8fd-4996-9b90-d0de2b6a238e 35 fields · synced May 30, 2026