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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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Natus® - 00382830055758

Contour-Flex Valve Unit, Regular, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O
NATUS MEDICAL INCORPORATED
NTCFRM
In Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
NTCFRM

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830055680

Contour-Flex Valve Unit, Small, High Pressure At 20 ml/hr: 12.7 - 18.0 cm H2O
NATUS MEDICAL INCORPORATED
NTCFSH
In Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O
NTCFSH

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830056045

Contour-Flex Valve Unit, Small, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O
NATUS MEDICAL INCORPORATED
NTCFSM
In Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
NTCFSM

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830055987

Contour-Flex Valve Unit, Regular, High Pressure At 20 ml/hr: 12.7 - 18.0 cm H2O
NATUS MEDICAL INCORPORATED
NTCFRH
In Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O
NTCFRH

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830055895

Contour-Flex Valve Unit, Small, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O
NATUS MEDICAL INCORPORATED
NTCFSL
In Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
NTCFSL

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830055833

Contour-Flex Valve Unit, Regular, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O
NATUS MEDICAL INCORPORATED
NTCFRL
In Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
NTCFRL

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036838

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSM
Not in Commercial Distribution

  • 10381780036838 ()
  • M272CFSM1 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFSM

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036821

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSL
Not in Commercial Distribution

  • 10381780036821 ()
  • M272CFSL1 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFSL

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036814

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSH
Not in Commercial Distribution

  • 10381780036814 ()
  • M272CFSH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFSH

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036807

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRM
Not in Commercial Distribution

  • 10381780036807 ()
  • M272CFRM1 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFRM

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036791

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRL
Not in Commercial Distribution

  • 10381780036791 ()
  • M272CFRL1 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFRL

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780036784

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRH
Not in Commercial Distribution

  • 10381780036784 ()
  • M272CFRH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFRH

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457589

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSL
Not in Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFSL

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457565

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Regular, Medium Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRM
Not in Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFRM

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457541

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Regular, High Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRH
Not in Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFRH

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457596

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Small, Medium Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSM
Not in Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFSM

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457572

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSH
Not in Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFSH

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457558

Contour-Flex Valve and Shunt System Contour-Flex Valve Unit, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRL
Not in Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFRL

  • Ventriculo-peritoneal/atrial shunt

SAFEDRAW(TM) TA4812SDT - 00886333621446

A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682144
In Commercial Distribution

  • 50886333621441 ()
  • 00886333621446 ()

  • 5cc restricted syringe stops at 2cc
682144

  • Arterial blood sampling kit

SAFEDRAW(TM) TA4812SD - 00886333621361

A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682136
In Commercial Distribution

  • 50886333621366 ()
  • 00886333621361 ()

  • 3cc restricted syringe stops at 2cc
682136

  • Arterial blood sampling kit

SAFEDRAW(TM) TA6012SD - 00886333621354

A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682135
In Commercial Distribution

  • 50886333621359 ()
  • 00886333621354 ()

  • 3cc restricted syringe stops at 2cc
682135

  • Arterial blood sampling kit

Pediatric Table, OPERON D 750-D 850 (EU) - 10841962110478

Pediatric Table, OPERON D 750-D 850 (EU)
Qfix
8000105
In Commercial Distribution

  • 10841962110478 ()

  • Side Rail Width
  • Width: 12.25 Inch
  • Width: 1 Inch
  • Table Width at Free End
  • Width: 21 Inch
  • Length: 36 Inch
  • Table Length
  • Table Width at Connection
8000105

  • Universal operating table top

Pediatric Table, OPERON D 750-D 850 (US) - 10841962110461

Pediatric Table, OPERON D 750-D 850 (US)
Qfix
8002074
In Commercial Distribution

  • 10841962110461 ()

  • Width: 1.12 Inch
  • Side Rail Width
  • Table Width at Free End
  • Table Width at Connection
  • Width: 21 Inch
  • Table Length
  • Length: 36 Inch
  • Width: 12.25 Inch
8002074

  • Universal operating table top

ReActiv8 Stimulation Lead - 05391527772262

Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packaged at OI.
MAINSTAY MEDICAL LIMITED
7M8165-005
In Commercial Distribution

  • 05391527772262 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

Lac-Mac - 00627755057129

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size 3XL
Lac-Mac Limited
005XFAB-3XL
In Commercial Distribution

  • 00627755057129 ()

  • Height: 58.25 Inch
  • Width: 31 Inch
005XFAB-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755056122

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size 2XL
Lac-Mac Limited
005XFAB-2XL
In Commercial Distribution

  • 00627755056122 ()

  • Height: 57.25 Inch
  • Width: 29 Inch
005XFAB-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755055125

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XL
Lac-Mac Limited
005XFAB-XL
In Commercial Distribution

  • 00627755055125 ()

  • Height: 56.25 Inch
  • Width: 27 Inch
005XFAB-XL

  • Surgical gown, reusable

Lac-Mac - 00627755053121

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size M
Lac-Mac Limited
005XFAB-M
In Commercial Distribution

  • 00627755053121 ()

  • Height: 54.25 Inch
  • Width: 23 Inch
005XFAB-M

  • Surgical gown, reusable

Lac-Mac - 00627755054128

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size L
Lac-Mac Limited
005XFAB-L
In Commercial Distribution

  • 00627755054128 ()

  • Height: 55.25 Inch
  • Width: 25 Inch
005XFAB-L

  • Surgical gown, reusable

Lac-Mac - 00627755052124

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size S
Lac-Mac Limited
005XFAB-S
In Commercial Distribution

  • 00627755052124 ()

  • Height: 53.25 Inch
  • Width: 21 Inch
005XFAB-S

  • Surgical gown, reusable

Lac-Mac - 00627755051127

Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XS
Lac-Mac Limited
005XFAB-XS
In Commercial Distribution

  • 00627755051127 ()

  • Height: 52.25 Inch
  • Width: 19 Inch
005XFAB-XS

  • Surgical gown, reusable

ReActiv8 Stimulation Lead - 05391527772279

Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8165-006
Not in Commercial Distribution

  • 05391527772279 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

ASSI - 00841645133896

Senn Retractor 16cm Dbl. Ended 3 Sharp Prongs At One End & 6.0 X 13mm Blade At The Other End
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK33316
In Commercial Distribution

  • 00841645133896 ()


  • Hand-held surgical retractor, reusable

NAMIC - 10193489047158

MTS VASCULAR KIT MED CEN AT BWLING GREEN
MEDLINE INDUSTRIES, INC.
60132011
In Commercial Distribution

  • 20193489047155 ()
  • 10193489047158 ()
60132011

  • Angiography kit

NAMIC - 10193489044232

MTS 3V KIT BAYLOR REG MED AT GRAPEVINE
MEDLINE INDUSTRIES, INC.
60070813
In Commercial Distribution

  • 20193489044239 ()
  • 10193489044232 ()
60070813

  • Angiography kit

NAMIC - 10193489062786

MTO,NEURO,KIT,CAPITAL HLTH SYS,AT,FULD
MEDLINE INDUSTRIES, INC.
65182728
In Commercial Distribution

  • 10193489062786 ()
  • 20193489062783 ()
65182728

  • Angiography kit

NA - 00643169420229

CUSTOM PACK 8C76R 20PK AT 1/4 ADPTO
MEDTRONIC, INC.
8C76R
In Commercial Distribution

  • 20643169420223 ()
  • 00643169420229 ()


  • Cardiopulmonary bypass system blood tubing set

PILLING - 14026704791566

CLAMP GLASSMAN STOMCH 2" AT JAW 9-1/2"
TELEFLEX INCORPORATED
IPN017577
In Commercial Distribution

  • 54026704791564 ()
  • 14026704791566 ()
P15687

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Oticon - 05707131142757

VGPC, ITC/ITE AT BE VIGO PRO CONNECT
Oticon A/S
106-29-690-10
In Commercial Distribution

  • 05707131142757 ()


  • Air-conduction hearing aid, in-the-ear

Oticon - 05707131130808

HT, ITE VC WL AT L BE HIT
Oticon A/S
106-31-270-10
In Commercial Distribution

  • 05707131130808 ()


  • Air-conduction hearing aid, in-the-ear
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