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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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Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
SMPL-AL-100
Not in Commercial Distribution

  • 00850054813114 ()
  • 10850054813111 ()
SMPL-AL-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
SMPL-AM-100
Not in Commercial Distribution

  • 00850054813107 ()
  • 10850054813104 ()
SMPL-AM-100

  • General-purpose medical fibre padding
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
SMPL-AS-100
Not in Commercial Distribution

  • 00850054813091 ()
  • 10850054813098 ()
SMPL-AS-100

  • General-purpose medical fibre padding
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC75
In Commercial Distribution

  • 10852528005961 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown diameter: 1.25 mm
7-10031-05

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200SOL145
In Commercial Distribution

  • 10852528005954 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 30 mm
  • Crown Diameter: 2.00 mm
7-10031-04

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL145
In Commercial Distribution

  • 10852528005947 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10031-03

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL145
In Commercial Distribution

  • 10852528005930 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10031-02

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC145
In Commercial Distribution

  • 10852528005923 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10031-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-200CLA145
In Commercial Distribution

  • 10852528005916 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 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: 20 mm
  • Crown Diameter: 2.00 mm
7-10030-11

  • Mechanical atherectomy system catheter, peripheral
SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005800 ()
7-10037-07

  • Atherectomy system saline/lubricant pump
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