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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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METACROSS OTW - 04540778154452

METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60040SW
In Commercial Distribution

  • 04540778154452 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 6.0 mm
BD-L60040SW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778154438

METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50040SW
In Commercial Distribution

  • 04540778154438 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 5.0 mm
BD-L50040SW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778154353

METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-LX0020SW
In Commercial Distribution

  • 04540778154353 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 7 Fr
  • Rated Burst Pressure; 12 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 10.0 mm
BD-LX0020SW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778154315

METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L80020SW
In Commercial Distribution

  • 04540778154315 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 8.0 mm
BD-L80020SW

  • Peripheral angioplasty balloon catheter, basic

WOTURE - B845X3021

This is suitable for a single user with limited mobility. It is suitable for indoor and outdoor use. The purpose of walking devices is to compensate for or at least improve restricted walking ability in users.
Intco Medical Industries, Inc.
X302
In Commercial Distribution

  • B845X3023 ()
  • B845X3021 ()


  • Walker tray

WOTURE - B845X3011

This is suitable for a single user with limited mobility. It is suitable for indoor and outdoor use. The purpose of walking devices is to compensate for or at least improve restricted walking ability in users.
Intco Medical Industries, Inc.
X301
In Commercial Distribution

  • B845X3013 ()
  • B845X3011 ()


  • Walker tray

GalaFLEX LITE - 00810054980599

GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100027-06
Not in Commercial Distribution

  • 00810054980599 ()

  • Outer Diameter: 8.9 Centimeter
GFLT0008

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980391

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-14
Not in Commercial Distribution

  • 00810054980391 ()

  • Outer Diameter: 7.6 Centimeter
SH3D14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980384

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-13
Not in Commercial Distribution

  • 00810054980384 ()

  • Outer Diameter: 7.6 Centimeter
SH3D13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980377

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-12
Not in Commercial Distribution

  • 00810054980377 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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