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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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LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55100-US-21
In Commercial Distribution

  • 00850041730059 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55150-US-21
In Commercial Distribution

  • 00850041730042 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55200-US-21
In Commercial Distribution

  • 00850041730035 ()


  • Arteriovenous endovascular stent-graft
Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution

  • M2138067M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8071M0H1
In Commercial Distribution

  • M2138071M0H15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K1
In Commercial Distribution

  • M2138063M0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K2
In Commercial Distribution

  • M2138063M0K25 ()
  • M2138063M0K22 ()

  • Total Volume: 3.0 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
STENT AB9U20150090 ABRE V01
MEDTRONIC, INC.
AB9U20150090
In Commercial Distribution

  • 00643169796478 ()

  • Stent Diameter 20 X 150 MM
  • Lumen Diameter 17.5 - 19 MM
  • Stent Length: 150.0 Millimeter
  • Minimum Sheath 9FR
  • Working Length 90 CM


  • Bare-metal peripheral venous stent
STENT AB9U20120090 ABRE V01
MEDTRONIC, INC.
AB9U20120090
In Commercial Distribution

  • 00643169796461 ()

  • Stent Length: 120.0 Millimeter
  • Stent Diameter 20 X 120 MM
  • Minimum Sheath 9FR
  • Working Length 90 CM
  • Lumen Diameter 17.5 - 19 MM


  • Bare-metal peripheral venous stent
STENT AB9U20100090 ABRE V01
MEDTRONIC, INC.
AB9U20100090
In Commercial Distribution

  • 00643169796454 ()

  • Stent Length: 100.0 Millimeter
  • Working Length 90 CM
  • Lumen Diameter 17.5 - 19 MM
  • Minimum Sheath 9FR
  • Stent Diameter 20 X 100 MM


  • Bare-metal peripheral venous stent
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