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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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SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL1
In Commercial Distribution

  • 50195594357342 ()
  • 10195594357344 ()
SOP23TKPL1

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL5
In Commercial Distribution

  • 50197106056743 ()
  • 10197106056745 ()
SOP23TKPL5

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Protective Sleeve_Elastic at Wrist and Top_Non-Sterile_120EA/CS
GRI Medical & Electronic Technology Co., Ltd.
60-3210
In Commercial Distribution

  • 26931918133697 ()
  • 16931918133690 ()


  • Isolation gown, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL4
In Commercial Distribution

  • 50197106023882 ()
  • 10197106023884 ()
SOP23TKPL4

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL2
In Commercial Distribution

  • 50195594742865 ()
  • 10195594742867 ()
SOP23TKPL2

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL3
In Commercial Distribution

  • 50195594875730 ()
  • 10195594875732 ()
SOP23TKPL3

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL7
In Commercial Distribution

  • 50197106111954 ()
  • 10197106111956 ()
SOP23TKPL7

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL8
In Commercial Distribution

  • 50197106158607 ()
  • 10197106158609 ()
SOP23TKPL8

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL6
In Commercial Distribution

  • 50197106086368 ()
  • 10197106086360 ()
SOP23TKPL6

  • Orthopaedic surgical procedure kit, non-medicated, single-use
EDOCS 120B-22 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 120 LPM AT 2250 PSI, 208-240V/50-60 HZ
Pacific Consolidated Industries LLC
EDOCS 120B-22
In Commercial Distribution

  • 00860007698224 ()
793980-001

  • Bulk oxygen concentration system
EDOCS 120B-21A FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ
Pacific Consolidated Industries LLC
EDOCS 120B-21A
In Commercial Distribution

  • 00860007698217 ()
793720-003

  • Bulk oxygen concentration system
EDOCS 120B-21 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ
Pacific Consolidated Industries LLC
EDOCS 120B-21
In Commercial Distribution

  • 00860007698200 ()
793720-001

  • Bulk oxygen concentration system
Senn Retractor 16cm Dbl. Ended 3 Blunt Prongs At One End & 6.0 X 13mm Blade At The Other End 6.0 X 13mm Blade At The Other End
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK33516
Not in Commercial Distribution

  • 00841645133919 ()


  • Hand-held surgical retractor, reusable
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
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
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
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
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
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 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
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