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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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Steam Sterilization Integrators
CERTOL INTERNATIONAL, LLC
TSI440
In Commercial Distribution

  • H816TSI4401 ()
  • H816TSI4400 ()
  • H816TSI4402 ()
TSI440-1

  • Chemical/physical sterilization process indicator
Enzymatic Presaturated Endoscopic Cleaning Sponge
MicroCare, LLC
SMQEZ2
In Commercial Distribution

  • H816SMQEZ22 ()
  • H816SMQEZ21 ()
  • H816QEZ21 ()
QEZ2

  • Medical device cleaning agent
Indicator Strips for Steam and Chemical Vapor
CERTOL INTERNATIONAL, LLC
SM4340
In Commercial Distribution

  • H816SM43402 ()
  • H816SM43401 ()
  • H816SM43400 ()
SM4340-1

  • Chemical/physical sterilization process indicator
No Description
CERTOL INTERNATIONAL, LLC
QEZ2
In Commercial Distribution

  • H816QEZ22 ()
  • H816QEZ21 ()
  • H816QEZ20 ()
QEZ2

  • Medical device cleaning agent
Needle Sheath Prop
CERTOL INTERNATIONAL, LLC
PNS500
In Commercial Distribution

  • H816PNS5001 ()
  • H816PNS5000 ()
  • H816PNS5002 ()
PNS500-1

  • Surgical instrument containment holder, single-use, non-sterile
Needle Sheath Prop
CERTOL INTERNATIONAL, LLC
PNS100
In Commercial Distribution

  • H816PNS1002 ()
  • H816PNS1001 ()
  • H816PNS1000 ()
PNS100-1

  • Surgical instrument containment holder, single-use, non-sterile
Self-Sealing Sterilization Pouch/Packaging 7.5" x 13"
CERTOL INTERNATIONAL, LLC
PM7513
In Commercial Distribution

  • H816PM75132 ()
  • H816PM75131 ()
  • H816PM75130 ()
PM7513-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 5.25" x 10"
CERTOL INTERNATIONAL, LLC
PM5410
In Commercial Distribution

  • H816PM54102 ()
  • H816PM54101 ()
  • H816PM54100 ()
PM5410-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 3.5" x 9"
CERTOL INTERNATIONAL, LLC
PM3590
In Commercial Distribution

  • H816PM35902 ()
  • H816PM35901 ()
  • H816PM35900 ()
PM3590-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 3.5" X 5.25"
CERTOL INTERNATIONAL, LLC
PM3554
In Commercial Distribution

  • H816PM35542 ()
  • H816PM35541 ()
  • H816PM35540 ()
PM3554-1

  • Sterilization packaging, single-use
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