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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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VITROS - 10758750008728

VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
1286293
In Commercial Distribution

  • 10758750008728 ()
  • 20758750008725 ()
1286293

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002528

VITROS Immunodiagnostic Products Troponin I ES Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802303
In Commercial Distribution

  • 10758750002528 ()
  • 20758750002525 ()
6802303

  • Troponin I IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002511

VITROS Immunodiagnostic Products Troponin I ES Calibrators
ORTHO CLINICAL DIAGNOSTICS
6802302
In Commercial Distribution

  • 10758750002511 ()
  • 20758750002518 ()
6802302

  • Troponin I IVD, kit, chemiluminescent immunoassay

AIMGEN MAX - 08800024953373

AIMGEN MAX Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
KM3015SA
In Commercial Distribution

  • 08800024953373 ()
MFX-3015S-CA

  • Screw endosteal dental implant, two-piece

AIMGEN MAX - 08800024953298

AIMGEN MAX Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
KM3010SA
In Commercial Distribution

  • 08800024953298 ()
MFX-3010S-CA

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913797

Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215M-SH
In Commercial Distribution

  • 08800024913797 ()
I3215M-SH

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913766

Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210M-SH
In Commercial Distribution

  • 08800024913766 ()
I3210M-SH

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913742

Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215-SH
In Commercial Distribution

  • 08800024913742 ()
I3215-SH

  • Screw endosteal dental implant, two-piece

KISSES MINI Internal Fixture - 08800024912592

Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208S
In Commercial Distribution

  • 08800024912592 ()
MFX-3208S-A

  • Screw endosteal dental implant, two-piece

KISSES MINI Internal Fixture - 08800024912585

Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210S
In Commercial Distribution

  • 08800024912585 ()
MFX-3210S-A

  • Screw endosteal dental implant, two-piece
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