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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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BIOLOX DELTA - 10603295033318

BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +5
DEPUY ORTHOPAEDICS, INC.
1365-28-720
In Commercial Distribution

  • 10603295033318 ()
136528720

  • Ceramic femoral head prosthesis

SIGMA LCS COMPLETE POROCOAT - 10603295025894

SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 5 CEMENTLESS
DEPUY (IRELAND)
1294-34-150
In Commercial Distribution

  • 10603295025894 ()
129434150

  • Coated knee tibia prosthesis

ATTUNE - 10603295057635

ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 15MM RM/LL CEMENTED SIZE 5/6
DEPUY (IRELAND)
1523-05-203
In Commercial Distribution

  • 10603295057635 ()
152305203

  • Knee arthroplasty wedge

ATTUNE - 10603295057628

ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM RM/LL CEMENTED SIZE 5/6
DEPUY (IRELAND)
1523-05-202
In Commercial Distribution

  • 10603295057628 ()
152305202

  • Knee arthroplasty wedge

ATTUNE - 10603295057611

ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 15MM LM/RL CEMENTED SIZE 5/6
DEPUY (IRELAND)
1523-05-103
In Commercial Distribution

  • 10603295057611 ()
152305103

  • Knee arthroplasty wedge

ATTUNE - 10603295057604

ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM LM/RL CEMENTED SIZE 5/6
DEPUY (IRELAND)
1523-05-102
In Commercial Distribution

  • 10603295057604 ()
152305102

  • Knee arthroplasty wedge

LUTONIX® Drug Coated Balloon - 00801741123320

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
LX351307605F
In Commercial Distribution

  • 00801741123320 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123313

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
LX351307405F
In Commercial Distribution

  • 00801741123313 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 40 Millimeter
LX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123306

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
LX3513061505F
In Commercial Distribution

  • 00801741123306 ()

  • Balloon Length, 150 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123290

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
LX3513061205F
In Commercial Distribution

  • 00801741123290 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
LX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated
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