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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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No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BTS 24V 901
In Commercial Distribution

  • 00816787020366 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BTS 24V 800
In Commercial Distribution

  • 00816787020359 ()


  • Laser Doppler blood flowmeter
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
301178-000
In Commercial Distribution

  • B0663011780006 ()
  • B0663011780000 ()
  • B0663011780005 ()
  • B0663011780004 ()
  • B0663011780003 ()
301178-000

  • Cardioplegia solution administration adaptor
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
301177-000
In Commercial Distribution

  • B0663011770006 ()
  • B0663011770000 ()
  • B0663011770005 ()
  • B0663011770004 ()
  • B0663011770003 ()
301177-000

  • Cardioplegia solution administration adaptor
No Description
STERITEC PRODUCT MFG. CO., INC.
61301606668
Not in Commercial Distribution

  • 10814434020421 ()
  • 00814434020424 ()
  • 00814434021162 ()
  • 00814434021179 ()
61301606668

  • Chemical/physical sterilization process indicator
No Description
WALK VASCULAR L.L.C.
WVSDUP
Not in Commercial Distribution

  • WVSDUP2 ()
  • B139WVSDUP0 ()


  • Mechanical atherectomy/thrombectomy drive system
No Description
BISCO INC.
U-3002P
Not in Commercial Distribution

  • D757U3002P1 ()

  • sixe text
U-3002P

  • Dentine bonding agent/set
No Description
BISCO INC.
U-3001P
Not in Commercial Distribution

  • D757U3001P1 ()

  • sixe text
U-3001P

  • Dentine bonding agent/set
No Description
BISCO INC.
U-2021P
Not in Commercial Distribution

  • D757U2021P0 ()

  • sixe text
U-2021P

  • Dentine bonding agent/set
No Description
Zimmer, Inc.
SSI005835
In Commercial Distribution

  • 00889024588240 ()
SSI005835

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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