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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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Lumio 2 Battery - 00850017651166

3.7V 4000mAh lithium-ion battery for Lumio 2
DermLite LLC
DLU2B
In Commercial Distribution

  • 00850017651166 ()
DLU2B

  • Dermatoscope, optical

NuSmile NeoMTA 2 - 00850008515026

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA22.5
In Commercial Distribution

  • 00850008515026 ()

  • Weight: 2.5 Gram


  • Hygroscopic dental cement

NuSmile NeoMTA 2 - 00850008515019

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA21.0
In Commercial Distribution

  • 00850008515019 ()

  • Weight: 1.0 Gram
none

  • Hygroscopic dental cement

NuSmile NeoMTA 2 - 00850008515002

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA20.5
In Commercial Distribution

  • 00850008515002 ()

  • Weight: 0.5 Gram
none

  • Hygroscopic dental cement

Size 2 Stander - 00850001752350

Multi Position Stander
RIFTON EQUIPMENT
S420
In Commercial Distribution

  • 00850001752350 ()


  • Manual stander

Madsen Astera 2 - 05713315010194

1066 MADSEN Astera 2, W/O HDA, US Only
Natus Medical Denmark ApS
8-04-13403
In Commercial Distribution

  • 05713315010194 ()
8-04-13403

  • Speech audiometer

Madsen Astera 2 - 05713315010187

1066 MADSEN Astera 2, US Only
Natus Medical Denmark ApS
8-04-13402
In Commercial Distribution

  • 05713315010187 ()
8-04-13402

  • Speech audiometer

MADSEN Astera 2 - 05713315007859

1066 MADSEN Astera 2 with ACPDS, Including HB-7 Headset, Insert Phone and DD450
Natus Medical Denmark ApS
8-04-13104
In Commercial Distribution

  • 05713315007859 ()
8-04-13104

  • Speech audiometer

MADSEN Astera 2 - 05713315007521

1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor
Natus Medical Denmark ApS
8-04-13124
In Commercial Distribution

  • 05713315007521 ()
8-04-13124

  • Speech audiometer

MADSEN Astera 2 - 05713315007477

1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC
Natus Medical Denmark ApS
8-04-12118
In Commercial Distribution

  • 05713315007477 ()
8-04-12118

  • Speech audiometer
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