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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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EMBOL-X Intra-Aortic Filter with Duraflo Coating - 00690103166361

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXLLD
In Commercial Distribution

  • 00690103166361 ()

  • ID 32-35 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXLLD

  • Embolic protection filtering guidewire

EMBOL-X Intra-Aortic Filter with Duraflo Coating - 00690103166354

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXMMD
In Commercial Distribution

  • 00690103166354 ()

  • ID 29-32 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXMMD

  • Embolic protection filtering guidewire

EMBOL-X Intra-Aortic Filter with Duraflo Coating - 00690103166347

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXSSD
In Commercial Distribution

  • 00690103166347 ()

  • ID 26-29 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXSSD

  • Embolic protection filtering guidewire

EMBOL-X Intra-Aortic Filter with Duraflo Coating - 00690103166330

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXSD
In Commercial Distribution

  • 00690103166330 ()

  • ID 22-26 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXSD

  • Embolic protection filtering guidewire

NeuroView™ - 10381780072300

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

Hermetic™ - 10381780071082

Hermetic™ Lumbar Catheter Closed Tip
Integra Lifesciences Corporation
INS5010
In Commercial Distribution

  • 10381780071082 ()
  • M269INS50101 ()

  • Catheter length: 80cm; 0.7mm ID x 1.5mm OD (all dimensions nominal)
INS5010

  • Lumbar cerebrospinal fluid drainage catheterization kit

Hermetic™ - 10381780071075

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

Hermetic™ - 10381780071068

Hermetic™ Ventricular Small Catheter Set
Integra Lifesciences Corporation
INS4000
In Commercial Distribution

  • 10381780071068 ()
  • M269INS40001 ()

  • Catheter length: 20cm; 1.3mm ID x 2.5mm OD (all dimensions nominal)
INS4000

  • Intracerebral infusion/drainage catheter, long-term

Hermetic™ - 10381780026211

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

Hermetic™ - 10381780023852

Hermetic™ Ventricular Catheter Set
Integra Lifesciences Corporation
INS8220
In Commercial Distribution

  • 10381780023852 ()
  • M269INS82201 ()

  • Catheter length: 35cm; 1.3mm ID x 2.7mm OD (all dimensions nominal)
INS8220

  • Intracerebral infusion/drainage catheter, long-term
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