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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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PREXION EVOLVE - 07899581345005

Panoramic with Cephalostat (2 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581345005 ()
16000004489

  • Cone beam computed tomography system, head/neck

PREXION EVOLVE - 07899581344992

Panoramic with Cephalostat (1 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581344992 ()
16000004583

  • Cone beam computed tomography system, head/neck

SXR / Saevo - 07899581340765

Panoramic with Cephalostat (1 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90 B
In Commercial Distribution

  • 07899581340765 ()
16000004378

  • Cone beam computed tomography system, head/neck

SXR / Saevo - 07899581340734

Panoramic with Cephalostat (2 sensors)
Alliage S/A Indústrias Médico Odontológica
AXR90 B
In Commercial Distribution

  • 07899581340734 ()
16000004370

  • Cone beam computed tomography system, head/neck

Dental CT Scanner AXR - 07899581335549

Panoramic with Cephalostat (2 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581335549 ()
16000003049

  • Cone beam computed tomography system, head/neck

Dental CT Scanner AXR - 07899581335532

Panoramic with Cephalostat (1 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581335532 ()
16000003048

  • Cone beam computed tomography system, head/neck

RTCII 2nd gen. - 10694644500063

12 DRUG MINICUP WITH ADULTERAN
AMERICAN BIO MEDICA CORPORATION
10-14BOX3AKE-03
Not in Commercial Distribution

  • 10694644500063 ()
  • 01069464455006 ()
10-14BOX3AKE-03

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator

RTCII 2nd gen. - 10694644500018

MINICUP WITH OPI300/METH500/CO
AMERICAN BIO MEDICA CORPORATION
10-12BOX3-030
Not in Commercial Distribution

  • 10694644500018 ()
  • 10694644550013 ()
10-12BOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator

Halyard - 10680651901382

Surgical Gowns with Huck Towels
O&M HALYARD, INC.
90138
In Commercial Distribution

  • 10680651901382 ()
  • 30680651901386 ()


  • Surgical gown, single-use

Halyard - 10680651900460

Surgical Gown, X-Large, with Towels
O&M HALYARD, INC.
90046
In Commercial Distribution

  • 30680651900464 ()
  • 10680651900460 ()
90046

  • Surgical gown, single-use
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