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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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Bone cutters - 04057176163158

Bone cutter CA 1,2mm TiN
DFS - DIAMON GmbH
110312T
In Commercial Distribution

  • 04057176163141 ()
  • 04057176163158 ()


  • Carbide dental bur, reusable

Alinity - 00380740135492

Alinity i CA 19-9XR Controls
Abbott GmbH
08P3210
In Commercial Distribution

  • 00380740135492 ()
08P3210

  • Cancer antigen 19-9 (CA19-9) IVD, control

Alinity - 00380740135430

Alinity i CA 15-3 Controls
Abbott GmbH
08P5110
In Commercial Distribution

  • 00380740135430 ()
08P5110

  • Cancer antigen 15-3 (CA15-3) IVD, control

ARCHITECT - 00380740145354

ARCHITECT CA 125 II Controls
Abbott GmbH
02K4511
In Commercial Distribution

  • 00380740145354 ()
02K4511

  • Cancer antigen 125 (CA125) IVD, control

BioMIM Mini Twin Brackets - 00840273916758

Roth .022 NHK CA LRGTRAY
World Class Technology Corporation
905.2034-LRGTRAY
In Commercial Distribution

  • 00840273916758 ()
905.2034-LRGTRAY

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273915881

Roth .018 NHK CA LRGTRAY
World Class Technology Corporation
905.1034-LRGTRAY
In Commercial Distribution

  • 00840273915881 ()
905.1034-LRGTRAY

  • Orthodontic bracket, metal

Henry Schein Maxima - 00304040058039

Maxima ELITE Electric CA Mini
HENRY SCHEIN, INC.
1125813
In Commercial Distribution

  • 00304040058039 ()
1125813

  • Dental power tool converter attachment, rotary

Medline - 10888277355620

MSN20001 COUNTERSINK,2.0-2.5 HEADED CA
MEDLINE INDUSTRIES, INC.
MSN20001RH
In Commercial Distribution

  • 10888277355620 ()
MSN20001RH

  • Cannulated surgical drill bit, single-use

Medline - 10888277355590

MSN20005 COUNTERSINK,4.0-4.5 HEADED CA
MEDLINE INDUSTRIES, INC.
MSN20005RH
In Commercial Distribution

  • 10888277355590 ()
MSN20005RH

  • Cannulated surgical drill bit, single-use

DETECTABUSE - 00810042683358

Menu CA Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008464
In Commercial Distribution

  • 00810042683358 ()
18008464

  • Multiple drugs of abuse IVD, control
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