FDA.reportPublic FDA data

SX-One MicroKnife

Primary DI
00860002094700
Brand
SX-One MicroKnife
Company
SONEX HEALTH, INC.
Model
600112-001
Catalog number
600112-001
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.
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002094717PackageGS13In Commercial Distribution
00860002094700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002094717008600020947178600020947170860002094717
00860002094700008600020947008600020947000860002094700

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-518-8780customerservice@sonexhealth.com

Regulatory Flags#

DUNS number
040211080
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02
07630894822582APTUSMedartis AGLXH2026-11-02
07630894822599APTUSMedartis AGLXH2026-11-02
07630894822629APTUSMedartis AGLXH2026-11-02
07630894822636APTUSMedartis AGLXH2026-11-02
07630894822643APTUSMedartis AGLXH2026-11-02
07630894822650APTUSMedartis AGLXH2026-11-02
07630894822681APTUSMedartis AGLXH2026-11-02
07630894823787APTUSMedartis AGLXH2026-11-02
00824846010746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00824846010753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00810017915446Pituitary Straight, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915453Pituitary Straight, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017915460Kerrison, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915477Kerrison, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017916085SABER-XA Angled Self-Retaining Driver, No. 20 HexalobeELEVATION SPINE, INC.LXH2026-10-30
00811382039348NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
03700569680121Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
03700569680138Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
B382SD9144842000Surgical DirectSurgical Direct, Inc.LXH2026-10-30