SONEX HEALTH, INC.

Address:950 Blue Gentian Road,Eagan,MN,55121,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

Clear

SX-One MicroKnife - 00860002094700 Catalog Number : 600112-001

Device Description : SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to t 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 Class :

Duns Number: 040211080

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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