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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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DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered
DYNASTY® BF SHELL 48MM GROUP B
Microport Orthopedics Inc.
DSBFGB48
In Commercial Distribution

  • DSBFGB48 ()
  • M684DSBFGB481 ()

  • Outer Diameter: 48 Millimeter
DSBFGB48

  • Metallic acetabulum prosthesis
DYNASTY® BF SHELL 46MM GROUP B
Microport Orthopedics Inc.
DSBFGB46
In Commercial Distribution

  • DSBFGB46 ()
  • M684DSBFGB461 ()

  • Outer Diameter: 46 Millimeter
DSBFGB46

  • Metallic acetabulum prosthesis
S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 18 B FITS: 18 x 13 STEM Cone: B
DEPUY ORTHOPAEDICS, INC.
53-5382
In Commercial Distribution

  • 10603295172505 ()
535382

  • Sleeve femoral/tibial extension, coated
S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 16 B FITS: 16 x 11 STEM Cone: B
DEPUY ORTHOPAEDICS, INC.
53-5362
In Commercial Distribution

  • 10603295172475 ()
535362

  • Sleeve femoral/tibial extension, coated
S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 20 B FITS: 20 x 15 STEM Cone: B
DEPUY ORTHOPAEDICS, INC.
53-5302
Not in Commercial Distribution

  • 10603295172413 ()
535302

  • Coated hip femur prosthesis, modular
SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005800 ()
7-10037-07

  • Atherectomy system saline/lubricant pump
Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FLP
In Commercial Distribution

  • 30852528005187 ()
  • 10852528005183 ()

  • Length; 325cm
  • Max Shaft Diameter; 0.012 inches
  • Max Tip Diameter; 0.014 inches
72010-01

  • Cardiac/peripheral vascular guidewire, single-use
CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
Cardiovascular Systems, Inc.
DBEC-150
In Commercial Distribution

  • 10852528005176 ()

  • Intro Sheath; 6Fr
  • Max OD; 0.061 inches
  • High speed; 120krpm
  • Low speed; 80krpm
  • Guidewire size OD; 0.012 inches
  • Shaft length; 135cm
  • Nose length; 10mm
  • Crown diameter; 1.5mm
  • Crown Type, Classic
70058-03

  • Mechanical atherectomy system, coronary, line-powered
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
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