Duns Number:040211080
Device Description: SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to transect th 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.
Catalog Number
600112-001
Brand Name
SX-One MicroKnife
Version/Model Number
600112-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
90718478-d8fd-4996-9b90-d0de2b6a238e
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
September 14, 2020
Package DI Number
00860002094717
Quantity per Package
3
Contains DI Package
00860002094700
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box