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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Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427R
In Commercial Distribution

  • 00191506043803 ()
M004PF61M427R

  • Cardiac irreversible electroporation system generator
Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427
In Commercial Distribution

  • 00191506043797 ()
M004PF61M427

  • Cardiac irreversible electroporation system generator
Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407R
In Commercial Distribution

  • 00191506042967 ()
M004PF61M407R

  • Cardiac irreversible electroporation system generator
Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407H
In Commercial Distribution

  • 00191506042950 ()
M004PF61M407H

  • Cardiac irreversible electroporation system generator
Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407D
In Commercial Distribution

  • 00191506042943 ()
M004PF61M407D

  • Cardiac irreversible electroporation system generator
Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407
In Commercial Distribution

  • 00191506042936 ()
M004PF61M407

  • Cardiac irreversible electroporation system generator
Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601D
In Commercial Distribution

  • 00191506043872 ()
M004PF61M601D

  • Cardiac irreversible electroporation system generator
Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601H
In Commercial Distribution

  • 00191506043865 ()
M004PF61M601H

  • Cardiac irreversible electroporation system generator
GENERATOR PSG100 PULSESELECT US
MEDTRONIC, INC.
PSG100
In Commercial Distribution

  • 00763000617530 ()


  • Cardiac irreversible electroporation system generator
GENERATOR PSG100 PULSESELECT LOANER US
MEDTRONIC, INC.
PSG100
In Commercial Distribution

  • 00763000897215 ()


  • Cardiac irreversible electroporation system generator
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (DPS) is intended for the delivery of Asclera®, an FDA-approved sclerosant, in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm. ScleroSafe is a sterile, single use device. The Catheter is packaged in a tray which includes all the accessories required for percutaneous introduction using the micropuncture technique. The catheter length is 350mm and is a 5F dual lumen with tapered - tip and two sets of Luer nozzles. ScleroSafe consists of the following components: Micro puncture needle, Nitinol guidewire and plastic torque tool, Dual Lumen Catheter, and Dual procedure syringes (DPS)to allow simultaneous withdrawal of blood and administration of fluids.
V.V.T. MED LTD
VAR350
In Commercial Distribution

  • 07290013043092 ()
VAR1350

  • Sclerotherapy dual injection/aspiration catheter
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (DPS) is intended for the delivery of Asclera®, an FDA-approved sclerosant, in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm. ScleroSafe is a sterile, single use device. The Catheter is packaged in a tray which includes all the accessories required for percutaneous introduction using the micropuncture technique. The catheter length is 150mm and is a 5F dual lumen with tapered - tip and two sets of Luer nozzles. ScleroSafe consists of the following components: Micro puncture needle, Nitinol guidewire and plastic torque tool, Dual Lumen Catheter, and Dual procedure syringes (DPS)to allow simultaneous withdrawal of blood and administration of fluids.
V.V.T. MED LTD
VAR150
In Commercial Distribution

  • 07290013043085 ()
VAR1150

  • Sclerotherapy dual injection/aspiration catheter
90-degree handle
ICECURE MEDICAL LTD
CP-2004059
In Commercial Distribution

  • 17290015487549 ()
  • 07290015487542 ()

  • Needle Gauge: 10 Gauge
  • Shaft Length: 140 Millimeter


  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7910000
Not in Commercial Distribution

  • 07290015487108 ()
FAP7910000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7400000
In Commercial Distribution

  • 07290015487092 ()

  • Shaft Length: 185 Millimeter
  • Needle Gauge: 10 Gauge
FAP7400000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7410000
In Commercial Distribution

  • 07290015487085 ()
  • 17290015487082 ()

  • Shaft Length: 185 Millimeter
  • Needle Gauge: 10 Gauge
FAP7410000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7800000
In Commercial Distribution

  • 07290015487054 ()
  • 17290015487051 ()

  • Shaft Length: 134 Millimeter
  • Needle Gauge: 13 Gauge
FAP7800000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7600000
In Commercial Distribution

  • 07290015487047 ()
  • 17290015487044 ()

  • Shaft Length: 124 Millimeter
  • Needle Gauge: 13 Gauge
FAP7600000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7200000
In Commercial Distribution

  • 07290015487030 ()
  • 17290015487037 ()

  • Shaft Length: 140 Millimeter
  • Needle Gauge: 10 Gauge
FAP7200000

  • Hand-held cryosurgical system handpiece tip
Cryoprobe - Use only with IceCure Cryogenic device.
ICECURE MEDICAL LTD
FAP7100000
In Commercial Distribution

  • 07290015487023 ()
  • 17290015487020 ()

  • Shaft Length: 127 Millimeter
  • Needle Gauge: 10 Gauge
FAP7100000

  • Hand-held cryosurgical system handpiece tip
straight handle
ICECURE MEDICAL LTD
CP-2004058
In Commercial Distribution

  • 07290015487535 ()
  • 17290015487532 ()

  • Needle Gauge: 10 Gauge
  • Stent Length: 140 Millimeter


  • Hand-held cryosurgical system handpiece tip
Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7820000
Not in Commercial Distribution

  • 07290015487078 ()

  • Shaft Length: 180 Millimeter
  • Needle Gauge: 13 Gauge
FAP7820000

  • Hand-held cryosurgical system handpiece tip
INUMI Flex Needle, 5 pack
Galvanize Therapeutics, Inc.
GTI-00054
In Commercial Distribution

  • 00850031859074 ()
  • 00850031859081 ()


  • Irreversible electroporation system endoscopic probe
PodiaTherm Disposable Kit
NEUROTHERM, INC.
PT-KIT-S
In Commercial Distribution

  • 05415067026576 ()
PT-KIT-S

  • Percutaneous radio-frequency ablation probe cannula, single-use
  • Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
  • Electrosurgical return electrode, single-use
Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software
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
No Description
SURETEK MEDICAL
7209686
In Commercial Distribution

  • B39072096861 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.
Biolase, Inc.
Diode Laser Tips - Starter Kit
Not in Commercial Distribution

  • 00647529004005 ()

  • Length: 9 Millimeter
  • Length: 7 Millimeter
  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
6400165

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Perio, 4-7
In Commercial Distribution

  • 00647529003381 ()
  • 00647529003329 ()

  • Outer Diameter: 400 Micrometer
  • Length: 7 Millimeter
7400068

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Surgical, 4-4
In Commercial Distribution

  • 00647529003374 ()
  • 00647529003312 ()

  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
7400067

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-Initiated, Perio, 3-9
In Commercial Distribution

  • 00647529003367 ()
  • 00647529003305 ()

  • Length: 9 Millimeter
  • Outer Diameter: 300 Micrometer
7400065

  • General/multiple surgical laser system beam guide, single-use, non-sterile
An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter.
Biolase, Inc.
EpiTips Surgical Assortment
Not in Commercial Distribution

  • 00647529001967 ()
6400564

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A tip kit containing 30 single-use laser tips intended for use with Biolase diode laser systems. The tips have the same core diameter of 300 microns and vary in length.
Biolase, Inc.
Perio EZ Tips Combo Pack, E3
In Commercial Distribution

  • 00647529001820 ()

  • Outer Diameter: 300 Micrometer
  • Length: 7 Millimeter
  • Length: 9 Millimeter
7400020

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A tip kit containing 30 single-use laser tips intended for use with diode laser systems. The tips have the same core diameter of 400 microns and vary in length.
Biolase, Inc.
Perio EZ Tips Combo Pack, E4
In Commercial Distribution

  • 00647529001813 ()

  • Length: 9 Millimeter
  • Length: 7 Millimeter
  • Outer Diameter: 400 Micrometer
7400019

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 3-4 Surgical
Not in Commercial Distribution

  • 00647529001943 ()
  • 00647529000489 ()

  • Length: 4 Millimeter
  • Outer Diameter: 300 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 4-4 Surgical
Not in Commercial Distribution

  • 00647529001912 ()
  • 00647529000472 ()

  • Outer Diameter: 400 Micrometer
  • Length: 4 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 4-7 Perio
Not in Commercial Distribution

  • 00647529001929 ()
  • 00647529000465 ()

  • Length: 7 Millimeter
  • Outer Diameter: 400 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 4-9 Perio
Not in Commercial Distribution

  • 00647529001936 ()
  • 00647529000458 ()

  • Outer Diameter: 400 Micrometer
  • Length: 9 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use non-sterile fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 3-9 Perio
Not in Commercial Distribution

  • 00647529000441 ()
  • 00647529001905 ()

  • Outer Diameter: 300 Micrometer
  • Length: 9 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
EpiTip 3-7 Perio
Not in Commercial Distribution

  • 00647529001899 ()
  • 00647529000434 ()

  • Length: 7 Millimeter
  • Outer Diameter: 300 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems.
Biolase, Inc.
E4-100 EZ Tips
In Commercial Distribution

  • 00647529001875 ()
  • 00647529000403 ()
  • 00647529001950 ()

  • Outer Diameter: 400 Micrometer
  • Length: 100 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such as Epic S-Series.
Biolase, Inc.
E4-60 EZTip
In Commercial Distribution

  • 00647529001868 ()
  • 00647529000397 ()

  • Length: 60 Millimeter
  • Outer Diameter: 400 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
E2-14 EZ Tips
In Commercial Distribution

  • 00647529001837 ()
  • 00647529000373 ()

  • Outer Diameter: 200 Micrometer
  • Length: 14 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
E3-7 EZ Tips
In Commercial Distribution

  • 00647529002643 ()
  • 00647529000366 ()

  • Outer Diameter: 300 Micrometer
  • Length: 7 Millimeter
7410002

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
E4-7 EZ Tips
In Commercial Distribution

  • 00647529000359 ()
  • 00647529002650 ()

  • Length: 7 Millimeter
  • Outer Diameter: 400 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
E2-4 EZ Tips
In Commercial Distribution

  • 00647529001806 ()
  • 00647529000342 ()

  • Outer Diameter: 200 Micrometer
  • Length: 4 Millimeter


  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
Biolase, Inc.
E3-4 EZ Tips
In Commercial Distribution

  • 00647529001790 ()
  • 00647529000335 ()

  • Length: 4 Millimeter
  • Outer Diameter: 300 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
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