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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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Hermetic™ II Hermetic™ Lumbar Drainage Accessory Kit
Integra Lifesciences Corporation
NL8508330
In Commercial Distribution

  • 10381780072393 ()
  • M269NL85083301 ()

  • Catheter length: 80 cm; 0.7mm ID x 1.5 OD (all dimensions nominal)
NL8508330

  • Intracerebral infusion/drainage catheter, long-term
Integra® Pudenz Ventricular Catheter Pudenz Ventricular Catheter with Stylet
Integra Lifesciences Corporation
NL8501519
In Commercial Distribution

  • 10381780072355 ()
  • M269NL85015191 ()

  • Length from tip to 90 degree angle: 9cm; Tubing: 1.3mm I.D. x 2.5mm O.D. (All dimensions nominal)
NL8501519

  • Intracerebral infusion/drainage catheter, long-term
Integra® Pudenz Ventricular Catheter with Stylet
Integra Lifesciences Corporation
NL8501504
In Commercial Distribution

  • 10381780072348 ()
  • M269NL85015041 ()

  • Tubing: 1.3mm I.D. x 2.2mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NL8501504

  • Intracerebral infusion/drainage catheter, long-term
NEUROVIEW™ Endoscopic Ventricular Catheter
Integra Lifesciences Corporation
NL8501328
In Commercial Distribution

  • 10381780072300 ()
  • M269NL85013281 ()

  • Catheter Length: 14.5cm; 1.4mm ID x 2.5mm OD (all dimensions nominal)
NL8501328

  • Intracerebral infusion/drainage catheter, long-term
STRIPED PUD. VENTRICULAR CATHETER The Integra Pudenz Ventricular Cather is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The Large Hole Model is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate-impregnated silicone elastomer, is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The catheter has four pairs of holes near the tip to facilitate drainage of CSF and to help reduce clogging of the catheter lumen. The extreme tip of the catheter is closed. The catheter incorporates markers at 5, 6, 7, 10 and 15 cm. A stylet is provided, along with a right-angle guide.
Integra Lifesciences Corporation
NL96001S01
In Commercial Distribution

  • 10381780071792 ()
  • M269NL96001S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 20cm (8") (all dimensions nominal)
NL96001S01

  • Intracerebral infusion/drainage catheter, long-term
Hermetic™ Large-Style Ventricular Catheter Set
Integra Lifesciences Corporation
INS4500
In Commercial Distribution

  • 10381780071075 ()
  • M269INS45001 ()

  • Catheter length: 35cm; 1.6mm ID x 3.0mm OD (all dimensions nominal)
INS4500

  • Intracerebral infusion/drainage catheter, long-term
The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.
NEWDEAL
230001SND
In Commercial Distribution

  • 10381780045892 ()
  • M248230001SND1 ()

  • 15.6mm length x 5.1mm width
230001SND

  • Phalangeal joint arthrodesis implant
The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.
NEWDEAL
230002SND
In Commercial Distribution

  • 10381780045908 ()
  • M248230002SND1 ()

  • 15.6mm length x 5.9mm width
230002SND

  • Phalangeal joint arthrodesis implant
The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents fourty (40) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
VC1
Not in Commercial Distribution

  • 10381780037248 ()
  • M272VC11 ()

  • Straight Vent. Cath. 25cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
VC1

  • Intracerebral infusion/drainage catheter, long-term
Hermetic™ Lumbar Catheter Open Tip
Integra Lifesciences Corporation
INS8330
In Commercial Distribution

  • 10381780026211 ()
  • M269INS83301 ()

  • Catheter length: 80cm; 0.7mm ID x 1.5mm OD (all dimensions nominal)
INS8330

  • Intracerebral infusion/drainage catheter, long-term
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