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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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COEfficient™ - 04046964334481

COE139 COEFFICIENT BALLOON 5 X 3 X 135
B BRAUN INTERVENTIONAL SYSTEMS, INC
611234
Not in Commercial Distribution

  • 04046964334481 ()
611234

  • Cardiac valvuloplasty catheter

COEfficient™ - 04046964334467

COE138 COEFFICIENT BALLOON 4 X 4 X 135
B BRAUN INTERVENTIONAL SYSTEMS, INC
611233
Not in Commercial Distribution

  • 04046964334467 ()
611233

  • Cardiac valvuloplasty catheter

COEfficient™ - 04046964334443

COE137 COEFFICIENT BALLOON 4 X 3 X 135
B BRAUN INTERVENTIONAL SYSTEMS, INC
611232
Not in Commercial Distribution

  • 04046964334443 ()
611232

  • Cardiac valvuloplasty catheter

Avitene - 00801741010521

Avitene Ultrafoam, 2 cm x 6.25 cm x 7 mm (3/4" x 2.5" x 1/4"), 12.5 sq cm, 7mm
Davol Inc.
1050020
In Commercial Distribution

  • 10801741010528 ()
  • 00801741010521 ()

  • Width: 2 Centimeter
  • Length: 6.25 Centimeter
  • Depth: 7 Millimeter
1050020

  • Collagen haemostatic agent, non-antimicrobial

LUTONIX® Drug Coated Balloon - 00801741163470

Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513072205F
In Commercial Distribution

  • 00801741163470 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX3513072205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163463

Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F
LUTONIX, INC.
LX3513071505F
In Commercial Distribution

  • 00801741163463 ()

  • Balloon Length, 150 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163456

Lutonix 035 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
LX3513071205F
In Commercial Distribution

  • 00801741163456 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163449

Lutonix 035 DCB, 7mm x 100mm x 130cm, 5F
LUTONIX, INC.
LX3513071005F
In Commercial Distribution

  • 00801741163449 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 100 Millimeter
LX3513071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163432

Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
LX351307805F
In Commercial Distribution

  • 00801741163432 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163425

Lutonix 035 DCB, 6mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513062205F
In Commercial Distribution

  • 00801741163425 ()

  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 220 Millimeter
LX3513062205F

  • Peripheral angioplasty balloon catheter, drug-coated
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