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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Alinity i CA 19-9XR Reagent Kit 200 Tests
Abbott GmbH
08P3221
In Commercial Distribution

  • 00380740155919 ()
08P3221

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 1000 Tests
Abbott GmbH
08P5130
In Commercial Distribution

  • 00380740131449 ()
08P5130

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 200 Tests
Abbott GmbH
08P5120
In Commercial Distribution

  • 00380740131432 ()
08P5120

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
AccuThrive #3 Scalpel Handle with Ruler 5EA/CA
AccuTec, Inc.
Scalpel Handle
In Commercial Distribution

  • 00843382114312 ()
AVSC-2000-0000

  • Scalpel handle, reusable
from antrum punch, delicate (Ø ca. 1.0 mm)
Spiggle & Theis Medizintechnik GmbH
30-450-92
In Commercial Distribution

  • 04250381887462 ()
30-450-92

  • Surgical instrument/endoscope cleaning utensil, single-use
from antrum punch standard (Ø ca. 1.6 mm)
Spiggle & Theis Medizintechnik GmbH
30-450-90
In Commercial Distribution

  • 04250381813911 ()
30-450-90

  • Surgical instrument/endoscope cleaning utensil, single-use
RESUS,ADL,MASK,OXY TUBE,RESV 10/CA
TRI-ANIM HEALTH SERVICES, INC.
301-C1000
In Commercial Distribution

  • 00812574020830 ()
  • 00812574025552 ()


  • Pulmonary resuscitator, manual, single-use
RESUS,ADL,MASK,OXY TUBE,RESV 10/CA
TRI-ANIM HEALTH SERVICES, INC.
301-C1000
In Commercial Distribution

  • 00812574020830 ()
  • 00812574025552 ()


  • Pulmonary resuscitator, manual, single-use
Essentials Cotton Sponge 2"x2" 8ply 5000/ca
HENRY SCHEIN, INC.
5702600
In Commercial Distribution

  • 00304040152119 ()
  • 10304040152116 ()
5702600

  • Woven gauze pad, non-sterile
KS 9.0 T Kit Monaural CA (velvet black)
Sonova AG
051-0159-P856
In Commercial Distribution

  • 07613389356564 ()
051-0159-P856

  • Air-conduction hearing aid, behind-the-ear
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