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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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5-0 BLACK SILK SUTURE 18", C-22 NEEDLE 16.2MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN1628S
In Commercial Distribution

  • 10889950000011 ()
  • 10889950001124 ()

  • 5-0
PSN1628S

  • Silk suture
The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-11TEC
In Commercial Distribution

  • 00860000846134 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(m)
In Commercial Distribution

  • 00860000846110 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(i)
In Commercial Distribution

  • 00860000846103 ()


  • Cardiopulmonary bypass system heating/cooling unit
GuideBlade, non-sterile, intended for inclusion in kits
Ambitus Medical Supplies LLC
AMB 1811
Not in Commercial Distribution

  • 20860000561918 ()
  • 00860000561914 ()
AMB 1811

  • Scalpel, single-use
Sterile GuideBlade
Ambitus Medical Supplies LLC
AMB 1746
In Commercial Distribution

  • 00860000561907 ()
  • 10860000561904 ()
  • 20860000561901 ()
  • 30860000561908 ()
AMB 1746-10

  • Scalpel, single-use
ClearPath Disposable Introducer
Clearmind Biomedical Inc.
AK-19-110
In Commercial Distribution

  • 00860000321341 ()
  • 00860000321334 ()
  • 00860000321358 ()


  • Intracerebral trocar blade
Reusable Vaginal Speculum
CEEK WOMEN'S HEALTH
NU001
In Commercial Distribution

  • 10860000270424 ()
  • 00860000270427 ()


  • Vaginal speculum, reusable
Single-Use Retraction Sheath
CEEK WOMEN'S HEALTH
VS000
In Commercial Distribution

  • 00860000270403 ()
  • 10860000270400 ()


  • Vaginal speculum, single-use
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