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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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ETCH GEL 37% S/P ENAMEL ETCH BL 1.2ML SYR*12 #FPPRACTIC002
Smarthealth, Inc.
SP620019
In Commercial Distribution

  • D766SP6200192 ()
  • D766SP6200191 ()
  • D766SP6200190 ()
SP620019

  • Dental etching solution
ETCH GEL 37% S/P ENAMEL ETCH BL 1.2ML SYR*4 #FPPRACTIC001
Smarthealth, Inc.
SP620018
In Commercial Distribution

  • D766SP6200182 ()
  • D766SP6200181 ()
  • D766SP6200180 ()
SP620018

  • Dental etching solution
S/P STERILIZATION POUCH 2.75X10IN*200 658-03082
Smarthealth, Inc.
SP440089
In Commercial Distribution

  • D766SP4400893 ()
  • D766SP4400891 ()
  • D766SP4400890 ()

  • 2.75X10 INCH
SP440089

  • Sterilization packaging, single-use
MASK EARLP S/P FLUID RESIST PNK*50 #658-00311
Smarthealth, Inc.
SP440069
In Commercial Distribution

  • D766SP4400692 ()
  • D766SP4400691 ()
  • D766SP4400690 ()
SP440069

  • Surgical/medical respirator, non-antimicrobial, single-use
MASK EARLP S/P FLUID RESIST BL*50 #658-00310
Smarthealth, Inc.
SP440068
In Commercial Distribution

  • D766SP4400682 ()
  • D766SP4400681 ()
  • D766SP4400680 ()
SP440068

  • Surgical/medical respirator, non-antimicrobial, single-use
MASK EARLP S/P BL*50 #658-00060
Smarthealth, Inc.
SP440056
In Commercial Distribution

  • D766SP4400562 ()
  • D766SP4400561 ()
  • D766SP4400560 ()
SP440056

  • Surgical/medical respirator, non-antimicrobial, single-use
MASK EARLP S/P PNK*50 #658-00059
Smarthealth, Inc.
SP440055
In Commercial Distribution

  • D766SP4400552 ()
  • D766SP4400551 ()
  • D766SP4400550 ()
SP440055

  • Surgical/medical respirator, non-antimicrobial, single-use
S/P BIO MONITOR MAIL 3 TEST *12 #SMP120
Smarthealth, Inc.
62099
In Commercial Distribution

  • D766620992 ()
  • D766620991 ()
  • D766620990 ()
62099

  • Biological sterilization indicator
Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm
Osteogenics Biomedical Inc
ZXSOCKET-5
In Commercial Distribution

  • D765ZXSOCKET51 ()
  • D765ZXSOCKET50 ()

  • Width: 5 Millimeter
  • Length: 17 Millimeter


  • Dental bone matrix implant, animal-derived
Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm
Osteogenics Biomedical Inc
ZXSOCKET-10
In Commercial Distribution

  • D765ZXSOCKET101 ()
  • D765ZXSOCKET100 ()

  • Width: 5 Millimeter
  • Length: 17 Millimeter


  • Dental bone matrix implant, animal-derived
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