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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EXCELSIUS GPS - 00193982192556

End Effector Guide Tube, 3.2mm
GLOBUS MEDICAL, INC.
6143.1712
In Commercial Distribution

  • 00193982192556 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192549

End Effector Guide Tube, 2.4mm
GLOBUS MEDICAL, INC.
6143.1704
In Commercial Distribution

  • 00193982192549 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192532

End Effector Guide Tube, 2.3mm
GLOBUS MEDICAL, INC.
6143.1703
In Commercial Distribution

  • 00193982192532 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192518

End Effector Guide Tube, 1.8mm
GLOBUS MEDICAL, INC.
6143.1698
In Commercial Distribution

  • 00193982192518 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192365

2.5mm Hex Driver
GLOBUS MEDICAL, INC.
6143.1827
In Commercial Distribution

  • 00193982192365 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192358

Cranial Drill Stop
GLOBUS MEDICAL, INC.
6143.1826
In Commercial Distribution

  • 00193982192358 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982185220

Patient Stabilization Stand
GLOBUS MEDICAL, INC.
6143.2505
In Commercial Distribution

  • 00193982185220 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982143473

Interchangeable Guide End Effector
GLOBUS MEDICAL, INC.
6143.2504
In Commercial Distribution

  • 00193982143473 ()


  • Robotic surgical arm system

Micromate - 09010279000411

The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
iSYS Medizintechnik GmbH
iONE
In Commercial Distribution

  • 09010279000411 ()


  • Robotic surgical arm system

mTrigger - 00863712000337

mTrigger Biofeedback System
MTRIGGER, LLC
BI2612/BK2613
In Commercial Distribution

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation system
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