FDA.reportPublic FDA data

TrackX

Primary DI
00857088008769
Brand
TrackX
Company
TrackX Technology, LLC
Model
ASC PROCEDURE KIT 1
Catalog number
980-3TX
Device description
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Published
2024-03-19
Public version status
Update
Distribution status
Not 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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
LLZSystem, Image Processing, Radiological
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857088008769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857088008769008570880087698570880087690857088008769

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-787-2259support@trackx.tech

Regulatory Flags#

DUNS number
080948525
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073646007TrackXTrackX Home Base Pin - 6mm x 100mm207-4TX2025-07-24
00850073646014TrackXTrackX Home Base Pin - 6mm x 150mm208-4TX2025-07-24
00850073646144TrackXACCESS-CALIBRATOR CUP 3 - MJF VSTX-3-45342026-05-26
00857088008684TrackXTrackX Insight Base - DS Disc Prep611-3TX2026-05-11
00850073646120TrackXTrackX AT INSERT-ADAPT 2 - MJF VSTX-3-45012026-04-08
00850073646106TrackXTrackX SE RETRACT ADAPT 2-BLADE - MJF VSTX-3-44692026-02-24
00857088008813TrackXTrackX NV RETRACT-ADAPT - MJF VSTX-3-42012024-07-08
00857088008844TrackXTrackX AT INSERT-ADAPTTX-3-42622025-12-08
00857088008875TrackXTrackX SE RETRACT-ADAPT 5L - MJF VS1002-3TX2025-02-07
00857088008820TrackXTrackX AT INSERT-ADAPT - MJF VSTX-3-42292024-08-15
00850073646045TrackXTrackX NV RETRACT-ADAPT1000-3TX2025-10-24
00857088008660TrackXTrackX NV INSERT-ADAPT1001-3TX2024-09-12
00850073646052TrackXHome Base Pin Snap203-3TX2025-10-24
00850073646069TrackXInitial Dilator Snap204-3TX2025-10-24
00850073646076TrackXCobb Snap205-3TX2025-10-24
00850073646083TrackXT-Handle Snap206-3TX2025-10-24
00850073646113TrackXTrackX AWLSHIDITX-4-41552025-10-15
00850073646038TrackXTrackX Modular Malleting AdapterTX-3-43692025-05-16
00857088008653TrackXTrackX Insight Base - NV/AT Disc Prep - MJF VSTX-3-40792024-03-13
00857088008646TrackXTrackX Insight Base - NV/AT Disc Prep - MJFTX-3-41662024-02-15

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08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
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05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
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08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
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EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
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