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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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OSV II® - 10381780033967

OSV II® Valve System WITH ANTECHAMBER AND INTEGRAL 13CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909704
In Commercial Distribution

  • 10381780033967 ()
  • M2729097041 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 13cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909704

  • Ventriculo-peritoneal/atrial shunt

OSV II® - 10381780033943

OSV II® Valve System 3 PIECES SYSTEM WITH ANTECHAMBER
Integra LifeSciences Switzerland Sàrl
909702
In Commercial Distribution

  • 10381780033943 ()
  • M2729097021 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909702

  • Ventriculo-peritoneal/atrial shunt

OSV II® - 10381780033936

OSV II® Valve Unit WITH 2 INTEGRAL CONNECTORS
Integra LifeSciences Switzerland Sàrl
909701
In Commercial Distribution

  • 10381780033936 ()
  • M2729097011 ()

  • Flow Regulation Valve: 18-30ml/h
909701

  • Ventriculo-peritoneal/atrial shunt

Integra® - 10381780431855

PICC Insertion Tray
INTEGRA PAIN MANAGEMENT
3405224
Not in Commercial Distribution

  • 10381780371755 ()
  • 30381780431859 ()
  • 10381780431855 ()
3405224

  • Peripherally-inserted central venous catheter

Salto Talaris® - 10381780510833

Tibial Tray, XL, Size 3
Ascension Orthopedics, Inc.
LJU993T
In Commercial Distribution

  • 10381780510833 ()

  • XL, Size 3
LJU993T

  • Mobile-bearing total ankle prosthesis

Salto Talaris® - 10381780510826

Tibial Tray, XL, Size 2
Ascension Orthopedics, Inc.
LJU992T
In Commercial Distribution

  • 10381780510826 ()

  • XL, Size 2
LJU992T

  • Mobile-bearing total ankle prosthesis

Salto Talaris® - 10381780510819

Tibial Tray, XL, Size 1
Ascension Orthopedics, Inc.
LJU991T
In Commercial Distribution

  • 10381780510819 ()

  • XL, Size 1
LJU991T

  • Mobile-bearing total ankle prosthesis

Salto Talaris® - 10381780510802

Tibial Tray, XL, Size 0
Ascension Orthopedics, Inc.
LJU990T
In Commercial Distribution

  • 10381780510802 ()

  • XL, Size 0
LJU990T

  • Mobile-bearing total ankle prosthesis

Salto Talaris® - 10381780510796

Talar Dome, Flat Cut, Size 0, Left
Ascension Orthopedics, Inc.
LJU820T
In Commercial Distribution

  • 10381780510796 ()

  • Size 0, Left
LJU820T

  • Mobile-bearing total ankle prosthesis

Salto Talaris® - 10381780510789

Talar Dome, Flat Cut, Size 0, Right
Ascension Orthopedics, Inc.
LJU810T
In Commercial Distribution

  • 10381780510789 ()

  • Size 0, Right
LJU810T

  • Mobile-bearing total ankle prosthesis
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