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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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Synergetics - 20841305108022

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

TRUPULSE™ Generator - 10846835025248

TRUPULSE Generator
Biosense Webster Inc
D141702
In Commercial Distribution

  • 10846835025248 ()
D141702

  • Cardiac irreversible electroporation system generator

Trivex System - 00840663106578

TRIVEX System Illuminator
Lemaitre Vascular, Inc.
7210351
In Commercial Distribution

  • 00840663106578 ()
7210351

  • Transillumination phlebectomy system illuminator

Trivex System - 00840663106530

Trivex System control unit with build in pump
Lemaitre Vascular, Inc.
7210386
In Commercial Distribution

  • 00840663106530 ()
7210386

  • Transillumination phlebectomy system control unit

FARASTAR™ - 00191506043872

Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601D
In Commercial Distribution

  • 00191506043872 ()
M004PF61M601D

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043865

Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601H
In Commercial Distribution

  • 00191506043865 ()
M004PF61M601H

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043841

Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601
In Commercial Distribution

  • 00191506043841 ()
M004PF61M601

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043827

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427D
In Commercial Distribution

  • 00191506043827 ()
M004PF61M427D

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043803

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427R
In Commercial Distribution

  • 00191506043803 ()
M004PF61M427R

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506042967

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407R
In Commercial Distribution

  • 00191506042967 ()
M004PF61M407R

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506042943

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407D
In Commercial Distribution

  • 00191506042943 ()
M004PF61M407D

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043858

Mapping System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M601R
In Commercial Distribution

  • 00191506043858 ()
M004PF61M601R

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043810

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427H
In Commercial Distribution

  • 00191506043810 ()
M004PF61M427H

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506043797

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M427
In Commercial Distribution

  • 00191506043797 ()
M004PF61M427

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506042950

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407H
In Commercial Distribution

  • 00191506042950 ()
M004PF61M407H

  • Cardiac irreversible electroporation system generator

FARASTAR™ - 00191506042936

Recording System Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M407
In Commercial Distribution

  • 00191506042936 ()
M004PF61M407

  • Cardiac irreversible electroporation system generator

iovera Smart Tip - 00816287020286

SMART TIP, STIMULATING (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190STIM-5
In Commercial Distribution

  • 00816287020279 ()
  • 00816287020286 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020231

SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2309-5
In Commercial Distribution

  • 00816287020224 ()
  • 00816287020231 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020217

SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190-5
In Commercial Distribution

  • 00816287020200 ()
  • 00816287020217 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020187

SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0801-5
In Commercial Distribution

  • 00816287020170 ()
  • 00816287020187 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020149

SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0309-5
In Commercial Distribution

  • 00816287020132 ()
  • 00816287020149 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020118

SMART TIP, STIMULATING (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0811-5
In Commercial Distribution

  • 00816287020101 ()
  • 00816287020118 ()


  • Hand-held cryosurgical system handpiece tip

Cryoprobe - 07290015487542

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 D3.4 mm/10G, 285 mm, Pencil, Elliptic. - 07290015487108

Cryoprobe-Use only with IceCure Cryogenic Device
ICECURE MEDICAL LTD
FAP7910000
Not in Commercial Distribution

  • 07290015487108 ()
FAP7910000

  • Hand-held cryosurgical system handpiece tip

Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic. - 07290015487092

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 D3.4 mm/10G, 185 mm, Trocar, Elliptic. - 07290015487085

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 D2.4 mm/13G, 134 mm, Trocar, Elliptic. - 07290015487054

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 D2.4 mm/13G, 124 mm, Trocar, Spheric. - 07290015487047

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 D3.4 mm/10G, 140 mm, Trocar, Elliptic. - 07290015487030

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 D3.4 mm/10G, 127 mm, Trocar, Spheric. - 07290015487023

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
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