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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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IPD - 08435566630255

Straight Multi-unit Ø 3.5 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630255 ()
IPD/AA-MN-02

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566630248

Straight Multi-unit Ø 3.5 H 1.0
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630248 ()
IPD/AA-MN-01

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566630231

Healing abutment GM H 7.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630231 ()
IPD/RB-DR-07

  • Dental implant suprastructure, temporary, preformed, single-use

IPD - 08435566630217

Straight Multi-unit GM H 4.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566630217 ()
IPD/RB-MR-04

  • Dental implant suprastructure, permanent, preformed

Diamondback Coronary - 10852528005169

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10852528005169 ()

  • Intro Sheath; 6 french
  • Max OD; 0.057 inches
  • High speed; 120 krpm
  • low speed; 80 krpm
  • Guidewire size OD; 0.012 inches
  • Shaft Length; 135 cm
  • Nose Length; 5mm
  • Crown Size; 1.25 mm
  • Crown Type, Classic
70058-02

  • Mechanical atherectomy system, coronary, line-powered

Viperslide - 10852528005121

VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant

Stealth - 10852528005015

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

Diamondback Peripheral - 10852528005961

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 - 10852528005954

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 - 10852528005947

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
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