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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Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-150CLA145
In Commercial Distribution

  • 10852528005909 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 15 mm
  • Crown Diameter: 1.50 mm
7-10030-10

  • Mechanical atherectomy system catheter, peripheral
200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-0
In Commercial Distribution

  • 10852528005688 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-01

  • Vascular guide-catheter, single-use
4gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-014
Not in Commercial Distribution

  • 10852528005626 ()
  • 30852528005620 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 300cm
7-10049-02

  • Peripheral vascular guidewire, manual
30gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-018
Not in Commercial Distribution

  • 30852528005606 ()
  • 10852528005602 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 300cm
7-10050-08

  • Peripheral vascular guidewire, manual
4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual
ViperWire, Advance, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL18
In Commercial Distribution

  • 10852528005466 ()
  • 30852528005460 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10035-02

  • Peripheral vascular guidewire, manual
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-175SOL180
In Commercial Distribution

  • 10852528005008 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 180cm
  • Nose Length: 30mm
  • Crown Diameter: 1.75mm
7-10031-09

  • Mechanical atherectomy system catheter, peripheral
Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope
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