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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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AlloX2 Magnetic Site Locator - M746AMSL010

AlloX2 Magnetic Site Locator For Use with SSP AlloX2 Magnetic Injection & Drain Ports
SPECIALTY SURGICAL PRODUCTS INC
AMSL01
Not in Commercial Distribution

  • M746AMSL011 ()
  • M746AMSL010 ()
AMSL01

  • Tissue expander injection port locator

HemoTemp II Activator - M74490000

No Description
BIOSYNERGY, INC.
9000
Not in Commercial Distribution

  • M74490001 ()
  • M74490000 ()


  • Heating block IVD

HemoCool Gel-Pak - M74481000

No Description
BIOSYNERGY, INC.
8100
Not in Commercial Distribution

  • M74481001 ()
  • M74481000 ()
8100

  • Hot/cold therapy pack, reusable

LabTemp 20 - M74460001

No Description
BIOSYNERGY, INC.
6000
Not in Commercial Distribution

  • M74460002 ()
  • M74460001 ()
  • M74460000 ()


  • Laboratory thermometer

StaFreez - M74450001

No Description
BIOSYNERGY, INC.
5000
Not in Commercial Distribution

  • M74450002 ()
  • M74450001 ()
  • M74450000 ()


  • Laboratory thermometer

HemoTemp II - M74430001

No Description
BIOSYNERGY, INC.
3000
Not in Commercial Distribution

  • M74430001 ()
  • M74430002 ()
  • M74430000 ()


  • Medical product temperature point indicator, thermochemical

HemoTemp - M74420001

No Description
BIOSYNERGY, INC.
2000
Not in Commercial Distribution

  • M74420002 ()
  • M74420001 ()
  • M74420000 ()


  • Medical product temperature point indicator, thermochemical

TempTrend II - M74411001

No Description
BIOSYNERGY, INC.
1100
Not in Commercial Distribution

  • M74411001 ()
  • M74411002 ()
  • M74411000 ()


  • Liquid-crystal patient thermometer, single-use

TempTrend - M74410001

No Description
BIOSYNERGY, INC.
1000
Not in Commercial Distribution

  • M74410002 ()
  • M74410001 ()
  • M74410000 ()


  • Liquid-crystal patient thermometer, single-use

RICHPLAT ORTHO PRP SYSTEM - M713FPRP200

The RICHPLAT ORTHO™ Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
FIDIA FARMACEUTICI SPA
FPRP20
In Commercial Distribution

  • M713FPRP200 ()
  • M713FPRP201 ()
FPRP20

  • Haematological concentrate system preparation kit, platelet concentration
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