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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ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
114-009AA
In Commercial Distribution

  • M204114009AA0 ()
  • 00813132020040 ()

  • Outer Diameter: 1.45 Millimeter
114-009

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-004AA
In Commercial Distribution

  • M204110004AA0 ()
  • 00813132020033 ()

  • Outer Diameter: 0.97 Millimeter
110-004

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

  • M204110003AA0 ()
  • 00813132020026 ()

  • Outer Diameter: 0.97 Millimeter
110-003

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-002AA
In Commercial Distribution

  • M204110002AA0 ()
  • 00813132020019 ()

  • Outer Diameter: 0.97 Millimeter
110-002

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

  • M204110001AA0 ()
  • 00813132020002 ()

  • Outer Diameter: 0.97 Millimeter
110-001

  • Atherectomy laser system beam guide-catheter, coronary
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
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
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
110-001
Not in Commercial Distribution

  • M2041100010 ()

  • Outer Diameter: 0.97 Millimeter
110-001

  • Atherectomy laser system beam guide-catheter, coronary
No Description
Spectranetics Corporation
120-009
In Commercial Distribution

  • 00813132025403 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 135 Centimeter
120-009

  • Atherectomy laser system beam guide-catheter, coronary
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46942
In Commercial Distribution

  • 00193493469420 ()

  • Needle Gauge: 17 Gauge
MCK2-17-75-5.5

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46939
In Commercial Distribution

  • 00193493469390 ()

  • Needle Gauge: 17 Gauge
MCK3-17-75-2

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46938
In Commercial Distribution

  • 00193493469383 ()

  • Needle Gauge: 17 Gauge
MCK3-17-50-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46936
In Commercial Distribution

  • 00193493469369 ()

  • Needle Gauge: 17 Gauge
MCK3-17-50-2

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46935
In Commercial Distribution

  • 00193493469352 ()

  • Needle Gauge: 17 Gauge
MCK3-17-150-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46934
In Commercial Distribution

  • 00193493469345 ()

  • Needle Gauge: 17 Gauge
MCK2-17-75-2

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Neurosurgical procedure kit, non-medicated, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46933
In Commercial Distribution

  • 00193493469338 ()

  • Needle Gauge: 17 Gauge
MCK2-17-50-4

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46932
In Commercial Distribution

  • 00193493469321 ()

  • Needle Gauge: 17 Gauge
MCK2-17-150-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
46929
In Commercial Distribution

  • 00193493469291 ()

  • Needle Gauge: 17 Gauge
MCK2-17-50-2

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-150-4
In Commercial Distribution

  • 10193493442024 ()
  • 00193493442027 ()
CRK-17-150-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-50-2
In Commercial Distribution

  • 10193493441959 ()
  • 00193493441952 ()
CRK-17-50-2

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-75-2
In Commercial Distribution

  • 10193493441911 ()
  • 00193493441914 ()
CRK-17-75-2

  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-50-4
In Commercial Distribution

  • 10193493440754 ()
  • 00193493440757 ()
CRK-17-50-4

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
40608
In Commercial Distribution

  • 00193493406081 ()

  • Needle Gauge: 17 Gauge
MCK2-17-75-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
40590
In Commercial Distribution

  • 00193493405909 ()

  • Needle Gauge: 17 Gauge
MCK3-17-100-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
40589
In Commercial Distribution

  • 00193493405893 ()

  • Needle Gauge: 17 Gauge
MCK3-17-75-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* Multi-Cooled Radiofrequency Kit
Avanos Medical, Inc.
40588
In Commercial Distribution

  • 00193493405886 ()

  • Needle Gauge: 17 Gauge
MCK2-17-100-4

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-75-4
In Commercial Distribution

  • 10193493393210 ()
  • 00193493393213 ()
CRK-17-75-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
COOLIEF* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
CRK-17-100-4
In Commercial Distribution

  • 10193493393180 ()
  • 00193493393183 ()
CRK-17-100-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
COOLIEF* SINERGY* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
SIK-17-75-4
In Commercial Distribution

  • 10193493997159 ()
  • 00193493997152 ()
SIK-17-75-4

  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
COOLIEF* SINERGY* Cooled Radiofrequency Probe Kit
Avanos Medical, Inc.
SIK-17-150-4
In Commercial Distribution

  • 10193493997142 ()
  • 00193493997145 ()
SIK-17-150-4

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
  • Neurosurgical procedure kit, non-medicated, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
INUMI Flex Needle, 5 pack
Galvanize Therapeutics, Inc.
GTI-00054
In Commercial Distribution

  • 00850031859074 ()
  • 00850031859081 ()


  • Irreversible electroporation system endoscopic probe
FMX G1 Generator
DOMAIN SURGICAL, INC.
G1
In Commercial Distribution

  • 00859729006004 ()
FMG1

  • Electrosurgical system generator
  • Electrosurgical/ultrasonic surgical system generator
FRX 2.0 Articualed Arm
ILOODA.CO.,LTD
FRX 2.0 Articualed Arm
In Commercial Distribution

  • 08800023200027 ()


  • Electrosurgical system
  • Dermatological carbon dioxide laser system
FRX 2.0 Main Unit
ILOODA.CO.,LTD
FRX 2.0 Main Unit
In Commercial Distribution

  • 08800023200010 ()


  • Dermatological carbon dioxide laser system
  • Electrosurgical system
25ga Bipolar Cautery
SYNERGETICS USA, INC.
53.00.25
In Commercial Distribution

  • 20841305108022 ()
  • 10841305101545 ()
53.00.25

  • Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
  • Electrosurgical system
TRIVEX System Illuminator
Lemaitre Vascular, Inc.
7210351
In Commercial Distribution

  • 00840663106578 ()
7210351

  • Transillumination phlebectomy system illuminator
Trivex System control unit with build in pump
Lemaitre Vascular, Inc.
7210386
In Commercial Distribution

  • 00840663106530 ()
7210386

  • Transillumination phlebectomy system control unit
SMART TIP, STIMULATING (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190STIM-5
In Commercial Distribution

  • 00816287020279 ()
  • 00816287020286 ()


  • Hand-held cryosurgical system handpiece tip
SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2309-5
In Commercial Distribution

  • 00816287020224 ()
  • 00816287020231 ()


  • Hand-held cryosurgical system handpiece tip
SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190-5
In Commercial Distribution

  • 00816287020200 ()
  • 00816287020217 ()


  • Hand-held cryosurgical system handpiece tip
SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0801-5
In Commercial Distribution

  • 00816287020170 ()
  • 00816287020187 ()


  • Hand-held cryosurgical system handpiece tip
SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0309-5
In Commercial Distribution

  • 00816287020132 ()
  • 00816287020149 ()


  • Hand-held cryosurgical system handpiece tip
SMART TIP, STIMULATING (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0811-5
In Commercial Distribution

  • 00816287020101 ()
  • 00816287020118 ()


  • Hand-held cryosurgical system handpiece tip
MTO TRIVEX TM SWEDISH KIT 230-240V
Smith & Nephew, Inc.
7205946
Not in Commercial Distribution

  • 03596010452528 ()
7205946

  • Transillumination phlebectomy system control unit
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