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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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SEPTODONT USA SEPTOETCH 12-1.6GM SYR
SEPTODONT, INC
01C2034
In Commercial Distribution

  • 00303620000635 ()

  • Weight: 1.5 Gram
01C2034

  • Dental etching solution
SEPTODONT ETCH 4 X 4GM KIT
SEPTODONT, INC
01C2032
In Commercial Distribution

  • 00303620000628 ()

  • Weight: 4 Gram
01C2032

  • Dental etching solution
No Description
SEPTODONT, INC
01C2008
In Commercial Distribution

  • 00303620000550 ()

  • Weight: 4 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C2006
In Commercial Distribution

  • 00303620000543 ()

  • Weight: 4 Gram
01C2006

  • Dental composite resin
No Description
SEPTODONT, INC
01C2004
In Commercial Distribution

  • 00303620000536 ()

  • Weight: 4 Gram
01C2004

  • Dental composite resin
SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR
SEPTODONT, INC
01C2003
In Commercial Distribution

  • 00303620000529 ()

  • Weight: 9 Gram
01C2003

  • Dental composite resin
SEPTODONT ADHERENCE REF SYR CLEAR 4G
SEPTODONT, INC
01C2002
In Commercial Distribution

  • 00303620000512 ()

  • Weight: 4 Gram
01C2002

  • Dental composite resin
ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QCS
In Commercial Distribution

  • 20814247020462 ()
  • 10814247020465 ()
  • 00814247020468 ()


  • Amniotic fluid leak detection device IVD
ROM Plus®, Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

  • 20814247020455 ()
  • 10814247020458 ()
  • 00814247020451 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-6000
In Commercial Distribution

  • 20814247020448 ()
  • 10814247020441 ()
  • 00814247020444 ()


  • Amniotic fluid leak detection device IVD
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