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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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Durepair™ - 10381780540786

Durepair™ 12.5cm x 20.0cm (5" x 8")
TEI BIOSCIENCES INC.
62158
In Commercial Distribution


  • Length: 12.5 Centimeter
  • Width: 20 Centimeter
  • Length: 5 Inch
  • Width: 8 Inch
62158

  • Dura mater graft, bovine

Durepair™ - 10381780540762

Durepair™ 2.5cm x 7.5cm (1" x 3")
TEI BIOSCIENCES INC.
62106
In Commercial Distribution


  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter
  • Length: 3 Inch
  • Width: 1 Inch
62106

  • Dura mater graft, bovine

Integra® - 10381780540588

Integra® Single Use Extended Tip Applicator 15cm
Integra Lifesciences Corporation
205115
In Commercial Distribution


  • Length: 15 Centimeter
20-5115

  • Open-surgery adhesive/sealant applicator, dual-channel

CODMAN® - 10381780538332

CODMAN® Right Angle Adaptor
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823052
In Commercial Distribution

82-3052

  • Cerebrospinal fluid shunt connector

CODMAN® BACTISEAL® - 10381780537151

CODMAN® BACTISEAL® Ventricular Catheter with Centimeter Markings with BACTISEAL Shunt System MR Conditional Contents: Ventricular Catheter 14cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
NS5525
In Commercial Distribution

  • 10381780537151 ()

  • Catheter Length: 14 Centimeter
NS5525

  • Intracerebral infusion/drainage catheter, long-term

CODMAN® BACTISEAL® - 10381780537045

BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit MR Conditional Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823088
In Commercial Distribution

  • 10381780537045 ()

  • Catheter Length: 14 Centimeter
  • Catheter Length: 120 Centimeter
82-3088

  • Intracerebral infusion/drainage catheter, short-term

CODMAN® BACTISEAL® - 10381780537038

BEVC BACTISEAL® Endoscopic Ventricular Catheter MR Conditional Contents: Ventricular Catheter 14cm (1), Right Angle Adapter (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823087
In Commercial Distribution

  • 10381780537038 ()

  • Catheter Length: 14 Centimeter
82-3087

  • Intracerebral infusion/drainage catheter, short-term

CODMAN® BACTISEAL® - 10381780537021

CODMAN® BACTISEAL® Clear Catheter 1.9mm I.D. Catheter Set MR SAFE Contents:35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
821750
In Commercial Distribution

  • 10381780537021 ()

  • Catheter Inner Diameter: 1.9 Millimeter
  • Catheter Length: 35 Centimeter
82-1750

  • Intracerebral infusion/drainage catheter, short-term

CODMAN® BACTISEAL® - 10381780537014

CODMAN® EVD BACTISEAL® 1.9mm I.D. Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
821749
In Commercial Distribution

  • 10381780537014 ()

  • Catheter Inner Diameter: 1.9 Millimeter
  • Catheter Length: 35 Centimeter
82-1749

  • Intracerebral infusion/drainage catheter, short-term

CODMAN® BACTISEAL® - 10381780537007

CODMAN® BACTISEAL® Distal Catheter Kit with BACTISEAL Shunt System MR CONDITIONAL Contents: Distal Catheter 120cm (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823074
In Commercial Distribution

  • 10381780537007 ()

  • Catheter Length: 120 Centimeter
82-3074

  • Peritoneal/atrial cerebrospinal fluid catheter
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