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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STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral
STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 15 mm
  • Crown diameter 1.50 mm
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral
No Description
H & O Equipments SA
35g cartridges for Freezpen
In Commercial Distribution

  • 25407008484501 ()
  • 15407008484504 ()
  • 05407008484507 ()
CL-N2O-35G-UBOX

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • 25407008484303 ()
  • 15407008484306 ()
  • 05407008484309 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • 25407008484204 ()
  • 15407008484207 ()
  • 05407008484200 ()
CL-N2O-16G-BOX

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • 25407008484105 ()
  • 15407008484108 ()
  • 05407008484101 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • 25407008484006 ()
  • 15407008484009 ()
  • 05407008484002 ()
CL-N2O-8G-BOX

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
Freezpen 35g
In Commercial Distribution

  • 15407008483514 ()
CL-FPU-36

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
Freezpen 35G
In Commercial Distribution

  • 15407008483507 ()
CL-FPU-35

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
Freezpen 16g
In Commercial Distribution

  • 15407008483316 ()
CL-FPU-19

  • General cryosurgical system, cryogen gas, mechanical
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