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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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Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
CERTOL INTERNATIONAL, LLC
PM2440
In Commercial Distribution

  • H816PM24402 ()
  • H816PM24401 ()
  • H816PM24400 ()
PM2440-1

  • Sterilization packaging, single-use
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT340
In Commercial Distribution

  • H816PIT3401 ()
  • H816PIT3402 ()
PIT340-1

  • Sterilization packaging tape
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT120
In Commercial Distribution

  • H816PIT1201 ()
  • H816PIT1202 ()
PIT120-1

  • Sterilization packaging tape
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT100
In Commercial Distribution

  • H816PIT1002 ()
  • H816PIT1001 ()
PIT100-1

  • Sterilization packaging tape
High-Efficiency Face Mask w/ Earloop
CERTOL INTERNATIONAL, LLC
PFLEL8
In Commercial Distribution

  • H816PFLEL82 ()
  • H816PFLEL81 ()
  • H816PFLEL80 ()
PFLEL8-1

  • Surgical/medical face mask, single-use
High-Efficiency Face Mask with Headband
CERTOL INTERNATIONAL, LLC
PFL008
In Commercial Distribution

  • H816PFL0082 ()
  • H816PFL0081 ()
  • H816PFL0080 ()
PFL008-1

  • Surgical/medical face mask, single-use
Chemical Sterilant, Formaldehyde
MicroCare, LLC
VC338
In Commercial Distribution

  • H816MVC3381 ()
  • H816MVC3380 ()
  • H816VC3380 ()
VC338-1

  • Formaldehyde device sterilant
Steam Sterilization Integrators
MicroCare, LLC
TSI440
In Commercial Distribution

  • H816MTSI4402 ()
  • H816MTSI4401 ()
  • H816MTSI4400 ()
  • H816TSI4401 ()
TSI440-1

  • Chemical/physical sterilization process indicator
Indicator Strips for Steam and Chemical Vapor
MicroCare, LLC
SM4340
In Commercial Distribution

  • H816MSM43402 ()
  • H816MSM43401 ()
  • H816MSM43400 ()
  • H816SM43401 ()
SM4340-1

  • Chemical/physical sterilization process indicator
Needle Sheath Prop
MicroCare, LLC
PNS500
In Commercial Distribution

  • H816MPNS5002 ()
  • H816MPNS5001 ()
  • H816MPNS5000 ()
  • H816PNS5001 ()
PNS500-1

  • Surgical instrument interim-placement holder, single-use
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