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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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HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP10

HedySeal Pro Pouches 2.25"x4" with Class 4 Indicators
AMD Medicom Inc
610HSP-10
Not in Commercial Distribution

  • D903610HSP102 ()
  • D903610HSP101 ()
  • D903610HSP10 ()
610HSP-10

  • Sterilization packaging, single-use

HedySeal Max Self-Sealing Sterilization Pouch - D903610HSM40

HedySeal Max Pouches 3.5"x9" with Class 4 indicator detachable strips
AMD Medicom Inc
610HSM-40
In Commercial Distribution

  • D903610HSM40 ()
  • D903610HSM401 ()
  • D903610HSM402 ()
610HSM-40

  • Sterilization packaging, single-use

STRING'EMS FLOSS THREADERS - D89760705411271

No Description
MAXILL, INC.
6070541127
In Commercial Distribution

  • D89760705411272 ()
  • D89760705411271 ()
  • D89760705411273 ()
  • D89760705411270 ()


  • Dental floss

SOLEIL - D838BC125SS2

Disposable Curing Light Sleeves
Premium Plus International Limited
125SS
In Commercial Distribution

  • D838BC125SS8 ()
  • D838BC125SS6 ()
  • D838BC125SS2 ()
  • D838BC125SS0 ()


  • Instrument/equipment drape, single-use, non-sterile

SOLEIL - D838BC123SS2

Disposable Curing Light Sleeves
Premium Plus International Limited
123SS
In Commercial Distribution

  • D838BC123SS8 ()
  • D838BC123SS6 ()
  • D838BC123SS2 ()
  • D838BC123SS0 ()


  • Instrument/equipment drape, single-use, non-sterile

Premium Plus - D8389903T2

MICRO APPLICATORS
Premium Plus International Limited
9903T
In Commercial Distribution

  • D8389903T8 ()
  • D8389903T6 ()
  • D8389903T2 ()
  • D8389903T0 ()


  • Dental material application tool, single-use

Premium Plus - D8389902T2

MICRO APPLICATORS
Premium Plus International Limited
9902T
In Commercial Distribution

  • D8389902T8 ()
  • D8389902T6 ()
  • D8389902T2 ()
  • D8389902T0 ()


  • Dental material application tool, single-use

Premium Plus - D8389901T2

MICRO APPLICATORS
Premium Plus International Limited
9901T
In Commercial Distribution

  • D8389901T8 ()
  • D8389901T6 ()
  • D8389901T2 ()
  • D8389901T0 ()


  • Dental material application tool, single-use

Premium Plus - D8389062

Disposable Mixing Wells
Premium Plus International Limited
906
In Commercial Distribution

  • D8389068 ()
  • D8389066 ()
  • D8389062 ()
  • D8389060 ()


  • Dental material mixing surface, chairside, single-use

Premium Plus - D838904T2

MICRO APPLICATORS
Premium Plus International Limited
904T
In Commercial Distribution

  • D838904T8 ()
  • D838904T6 ()
  • D838904T2 ()
  • D838904T0 ()


  • Dental material application tool, single-use
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