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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OWL GASSERIAN GANGLION SET (Thermocouple)
Diros Technology Inc
463-001-TC-S
In Commercial Distribution

  • 00825114000698 ()
463-001-TC-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
SET OF 2, GASSERIAN GANGLION LESION ELECTRODES AND STYLETS
Diros Technology Inc
463-005-S
In Commercial Distribution

  • 00825114000674 ()
463-005-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
OWL GASSERIAN GANGLION R.F. PROBE/TEMPERATURE SENSOR
Diros Technology Inc
463-002-S
In Commercial Distribution

  • 00825114000667 ()
463-002-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
OWL GASSERIAN GANGLION SET (TRIGEMINAL SET OR TIC SET) (Thermistor)
Diros Technology Inc
463-001-S
In Commercial Distribution

  • 00825114000650 ()
463-001-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
AUTOCLAVE CASE
Diros Technology Inc
466-PB4-S
In Commercial Distribution

  • 00825114000643 ()
466-PB4-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
SET OF 2, DEPTH STOPPERS
Diros Technology Inc
463-024-S
In Commercial Distribution

  • 00825114000636 ()
463-024-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
SET OF 2, PROTECTOR TUBES FOR STORING ELECTRODE
Diros Technology Inc
463-105-S
In Commercial Distribution

  • 00825114000629 ()
463-105-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
OWL REUSABLE TASKER THALAMOTOMY LESION ELECTRODE,TEMPERATURE SENSING
Diros Technology Inc
468-101-S
In Commercial Distribution

  • 00825114000605 ()
468-101-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
OWL TASKER INTRACRANIAL ELECTRODE SET (18 GA.)
Diros Technology Inc
468-100-S
In Commercial Distribution

  • 00825114000599 ()
468-100-S

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSN150 REUSE NITINL 150MM 16G-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSN150
In Commercial Distribution

  • 00763000155247 ()

  • Length: 150.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSN100 REUSE NITINL 100MM 16G-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSN100
In Commercial Distribution

  • 00763000155230 ()

  • Length: 100.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSN050 REUSE NITINOL 50MM 16G-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSN050
In Commercial Distribution

  • 00763000155223 ()

  • Length: 50.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSR150 REUSABLE SS 150MM 16-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSR150
In Commercial Distribution

  • 00763000155216 ()

  • Length: 150.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSR100 REUSABLE SS 100MM 16-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSR100
In Commercial Distribution

  • 00763000155209 ()

  • Length: 100.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSR050 REUSABLE SS 50MM 16-22G
MEDTRONIC SOFAMOR DANEK, INC.
APSR050
In Commercial Distribution

  • 00763000155193 ()

  • Length: 50.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
PROBE APSC06 150MM 12MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC06
In Commercial Distribution

  • 00763000153496 ()

  • Needle Gauge: 17.0 Gauge
  • Length: 150.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
PROBE APSC05 100MM 12MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC05
In Commercial Distribution

  • 00763000153489 ()

  • Length: 100.0 Millimeter
  • Needle Gauge: 17.0 Gauge


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
PROBE APSC04 50MM 12MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC04
In Commercial Distribution

  • 00763000153472 ()

  • Needle Gauge: 17.0 Gauge
  • Length: 50.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
PROBE APSC03 150MM 10MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC03
In Commercial Distribution

  • 00763000153465 ()

  • Length: 150.0 Millimeter
  • Needle Gauge: 17.0 Gauge


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
PROBE APSC02 100MM 10 MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC02
In Commercial Distribution

  • 00763000153458 ()

  • Needle Gauge: 17.0 Gauge
  • Length: 100.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
PROBE APSC01 50MM 10MM ENHANCED
MEDTRONIC SOFAMOR DANEK, INC.
APSC01
In Commercial Distribution

  • 00763000153441 ()

  • Needle Gauge: 17.0 Gauge
  • Length: 50.0 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Rulo Probe 16g x 15cm w/ 10mm Active Area No Introducer
EPIMED INTERNATIONAL, INC
301-1815
In Commercial Distribution

  • 10818788023480 ()
  • 00818788023483 ()

  • 10mm Active Tip
  • 15cm
  • 18g
  • Needle Gauge: 18 Gauge
  • Length: 15 Centimeter
  • Length: 10 Millimeter
301-1815

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RFEL-R200-IE
In Commercial Distribution

  • 05060224334010 ()

  • Catheter Length: 200 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
Rulo Probe 16g x 15cm w/ 10mm Active Area No Introducer
EPIMED INTERNATIONAL, INC
301-1615
In Commercial Distribution

  • 10818788023473 ()
  • 00818788023476 ()

  • Needle Gauge: 16 Gauge
  • Length: 15 Centimeter
  • Length: 10 Millimeter
  • 16g
  • 15cm
  • 10mm Active Tip
301-1615

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter,3 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm
Covidien LP
CF7-3-60
In Commercial Distribution

  • 10884521174924 ()

  • Length: 60 Centimeter
  • Catheter Gauge: 7 French


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm
Covidien LP
CF7-7-60
In Commercial Distribution

  • 10884521058071 ()

  • Catheter Gauge: 7 French
  • Length: 60 Centimeter


  • Peripheral vascular electrocautery catheter, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 100 cm
Covidien LP
CF7-7-100
In Commercial Distribution

  • 10884521058057 ()

  • Length: 100 Centimeter
  • Catheter Gauge: 7 French


  • Peripheral vascular electrocautery catheter, single-use
Venus Viva applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
VENUS CONCEPT LTD
AS110011
In Commercial Distribution

  • 07290016540376 ()
  • 07290016540321 ()


  • Radio-frequency skin contouring system applicator, bipolar
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
2000
In Commercial Distribution

  • 07290015461009 ()

  • Weight: 890 Kilogram
EXABLATE 2000

  • Therapeutic oncological/gynaecological ultrasound system
Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.
INSIGHTEC LTD
4000 Type 1.1
In Commercial Distribution

  • 07290019402558 ()
SYS004000-CA

  • Ultrasonic hyperthermia system
No Description
SURETEK MEDICAL
7209686
In Commercial Distribution

  • B39072096861 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H702530
In Commercial Distribution

  • 05415067029713 ()
H702530

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H702517-T
In Commercial Distribution

  • 05415067028181 ()
H702517-T

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H702517
In Commercial Distribution

  • 05415067028174 ()
H702517

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H702518
In Commercial Distribution

  • 05415067027870 ()
H702518

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
120-009
Not in Commercial Distribution

  • M2041200090 ()

  • Outer Diameter: 2.0 Millimeter
120-009

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
120-008
Not in Commercial Distribution

  • M2041200080 ()

  • Outer Diameter: 2.0 Millimeter
120-008

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
117-205
Not in Commercial Distribution

  • M2041172050 ()

  • Outer Diameter: 1.65 Millimeter
117-205

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
117-016
Not in Commercial Distribution

  • M2041170160 ()

  • Outer Diameter: 1.75 Millimeter
117-016

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
114-009
Not in Commercial Distribution

  • M2041140090 ()

  • Outer Diameter: 1.45 Millimeter
114-009

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-004
Not in Commercial Distribution

  • M2041100040 ()

  • Outer Diameter: 0.97 Millimeter
110-004

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-003
Not in Commercial Distribution

  • M2041100030 ()

  • Outer Diameter: 0.97 Millimeter
110-003

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-002
Not in Commercial Distribution

  • M2041100020 ()

  • Outer Diameter: 0.97 Millimeter
110-002

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-001
Not in Commercial Distribution

  • M2041100010 ()

  • Outer Diameter: 0.97 Millimeter
110-001

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-001AB
In Commercial Distribution

  • 00813132025489 ()

  • Outer Diameter: 0.97 Millimeter
110-001

  • Atherectomy laser system beam guide-catheter, coronary
No Description
Spectranetics Corporation
110-002
In Commercial Distribution

  • 00813132025472 ()

  • Outer Diameter: 0.97 Millimeter
  • Length: 135 Centimeter
110-002

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-003AB
In Commercial Distribution

  • 00813132025465 ()

  • Outer Diameter: 0.97 Millimeter
110-003

  • Atherectomy laser system beam guide-catheter, coronary
No Description
Spectranetics Corporation
110-004
In Commercial Distribution

  • 00813132025458 ()

  • Outer Diameter: 0.97 Millimeter
  • Length: 135 Centimeter
110-004

  • Atherectomy laser system beam guide-catheter, coronary
No Description
Spectranetics Corporation
114-009
In Commercial Distribution

  • 00813132025441 ()

  • Outer Diameter: 0.97 Millimeter
  • Length: 135 Centimeter
114-009

  • Atherectomy laser system beam guide-catheter, coronary
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