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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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AOH AUX PACK 1 OF 2 CMC
Cardinal Health 200, LLC
SCVCGAPA57
In Commercial Distribution

  • 50198956116496 ()
  • 10198956116498 ()
SCVCGAPA57

  • Cardiothoracic surgical procedure kit, medicated, single-use
AOH AUX PACK 1 OF 2 CMC
Cardinal Health 200, LLC
SCVCGAPA58
In Commercial Distribution

  • 50198956121483 ()
  • 10198956121485 ()
SCVCGAPA58

  • Cardiothoracic surgical procedure kit, medicated, single-use
Box of ten (10) MODD1 Infusion Sets
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 10850037806048 ()
  • 00850037806041 ()
MTL-67

  • Electric infusion pump administration set, single-use
Box of ten (10) MODD1 Insulin Cartridges
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 10850037806024 ()
  • 00850037806027 ()
MTL-34

  • Ambulatory insulin infusion pump reservoir
DISPOSABLE AL GOLD KIT PACK OF 5
Tulip Medical Products
DPK-ALGOLD-05
In Commercial Distribution

  • 00819127024147 ()


  • Autologous adipose tissue reinjection set
The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS® powder and monomer liquid. PALACOS® R pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Heraeus Medical GmbH
R pro
In Commercial Distribution

  • 04260102135970 ()
  • 04260102135994 ()
  • 04260102135987 ()
5075299

  • Orthopaedic cement, non-antimicrobial
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX282845-J
In Commercial Distribution

  • 00850007370077 ()

  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Millimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 45 Millimeter
TV-EX282845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX222245-J
In Commercial Distribution

  • 00850007370060 ()

  • Stent Diameter: 22 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 14 Femtometer
  • Lumen/Inner Diameter: 12 Femtometer
  • Stent Length: 45 Millimeter
TV-EX222245-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX181845-J
In Commercial Distribution

  • 00850007370053 ()

  • Stent Diameter: 18 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX181845-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX161645-J
In Commercial Distribution

  • 00850007370046 ()

  • Stent Length: 16 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 13 Femtometer
  • Lumen/Inner Diameter: 11 Femtometer
  • Stent Length: 45 Millimeter
TV-EX161645-J

  • Abdominal aorta endovascular stent-graft
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