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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Phosphor Imaging Plates compatible AT - Type #1
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
AT-1
In Commercial Distribution

  • 00817169023593 ()
AT-1

  • Digital imaging cassette/storage phosphor screen, dental
Phosphor Imaging Plates compatible AT - Type #0
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
AT-0
In Commercial Distribution

  • 00817169023586 ()
AT-0

  • Digital imaging cassette/storage phosphor screen, dental
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPL9
In Commercial Distribution

  • 50197106923687 ()
  • 10197106923689 ()
SOP23TKPL9

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKP10
In Commercial Distribution

  • 50197106942497 ()
  • 10197106942499 ()
SOP23TKP10

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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
SOP23TKPLE
In Commercial Distribution

  • 50197106416974 ()
  • 10197106416976 ()
SOP23TKPLE

  • 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
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPLF
In Commercial Distribution

  • 50197106726493 ()
  • 10197106726495 ()
SOP23TKPLF

  • 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
SOP23TKPL6
In Commercial Distribution

  • 50197106086368 ()
  • 10197106086360 ()
SOP23TKPL6

  • 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
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
SOP23TKPLA
In Commercial Distribution

  • 50195594188090 ()
  • 10195594188092 ()
SOP23TKPLA

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM SHOULDER W PCH PK
Cardinal Health 200, LLC
SOP23SHPLA
In Commercial Distribution

  • 50195594188076 ()
  • 10195594188078 ()
SOP23SHPLA

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TTL KN REPLMNT PK
Cardinal Health 200, LLC
SOP23TKPLB
In Commercial Distribution

  • 50195594374592 ()
  • 10195594374594 ()
SOP23TKPLB

  • Orthopaedic surgical procedure kit, non-medicated, single-use
SC AT PELHAM SHOULDER W PCH PK
Cardinal Health 200, LLC
SOP23SHPLB
In Commercial Distribution

  • 50195594374578 ()
  • 10195594374570 ()
SOP23SHPLB

  • 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
SOP23TKPL4
In Commercial Distribution

  • 50197106023882 ()
  • 10197106023884 ()
SOP23TKPL4

  • Orthopaedic surgical procedure kit, non-medicated, single-use
V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Respironics California, Inc.
1076709
In Commercial Distribution

  • 00884838033832 ()
1076709

  • Portable electric ventilator
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
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
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
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
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
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
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 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 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 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 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 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 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
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
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
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)
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)
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
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
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
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
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
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
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
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
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