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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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Ovation iX Iliac Stent Graft - 00850007370190

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1428120-J
In Commercial Distribution

  • 00850007370190 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 120 Millimeter
TV-IL1428120-J

  • Abdominal aorta endovascular stent-graft

Ovation iX Iliac Stent Graft - 00850007370091

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1428140-J
In Commercial Distribution

  • 00850007370091 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 140 Millimeter
TV-IL1428140-J

  • Abdominal aorta endovascular stent-graft

Ovation iX Iliac Stent Graft - 00850007370008

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1428160-J
In Commercial Distribution

  • 00850007370008 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 28 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 15 Femtometer
  • Lumen/Inner Diameter: 13 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1428160-J

  • Abdominal aorta endovascular stent-graft

Revanesse Lips+ with Lidocaine 1.2 mL - 10669808003032

Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a biocompatible, biodegradable, non-pyrogenic, sterile, injectable viscoelastic clear colorless hydrogel based on bioresorbable BDDE cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration) containing 0.3% lidocaine. The HA is produced by the Streptococcus species of bacteria. The gel is delivered in a pre-filled disposable glass syringe. Each syringe is fitted with a Luer lock adaptor, a plunger rod, a rubber stopper tip cap, and a finger grip. Each box of Revanesse® Lips+ contains two 1.2 mL syringes of Revanesse® Lips+ along with two 0.5-inch 30-gauge sterile needles. The syringe is labeled with the product name, the manufacturer, lot number, and expiration date. There is a removable portion of the label, which can be affixed to the patient record.
Prollenium Medical
40149
In Commercial Distribution

  • 10669808003032 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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