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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Single use Navigation Kit of the IMACTIS® CT-NAVIGATION system
IMACTIS
I10100
In Commercial Distribution

  • B681I101002 ()
MA-I10100

  • Electromagnetic surgical navigation device tracking system
Non-sterile needle holder of the IMACTIS® CT-NAVIGATION system
IMACTIS
A10200
In Commercial Distribution

  • B681A102001 ()


  • Electromagnetic surgical navigation device tracking system
Navigation System
Covidien LP
AAS00161-20R
In Commercial Distribution

  • 10884521199996 ()
AAS00161-20R

  • Electromagnetic surgical navigation device tracking system
Navigation System
Covidien LP
AAS00161-20
In Commercial Distribution

  • 10884521199989 ()


  • Electromagnetic surgical navigation device tracking system
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution

  • 00843152104000 ()
SW-1

  • Electromagnetic surgical navigation device tracking system
IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
Centerline Biomedical, Inc.
T02111
In Commercial Distribution

  • 10843152103024 ()
  • 00843152103027 ()
T02111

  • Electromagnetic surgical navigation device tracking system
IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution

  • 10843152103000 ()
  • 00843152103003 ()
TP-1

  • Electromagnetic surgical navigation device tracking system
Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution

  • 10843152102058 ()
  • 00843152102051 ()
H01035

  • Electromagnetic surgical navigation device tracking system
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
MC-1
In Commercial Distribution

  • 00843152100002 ()
MC-1

  • Electromagnetic surgical navigation device tracking system
X EP System Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-R-FF-01
In Commercial Distribution

  • 05415067032201 ()
ENSITE-R-FF-01

  • Electromagnetic surgical navigation device tracking system
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