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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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BioMIM Mini Twin Brackets - 00840273915829

Roth .018 HKS 3, 4, CA
World Class Technology Corporation
905.1031
In Commercial Distribution

  • 00840273915829 ()
905.1031

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273915812

Roth .018 HKS 3 CA LRGTRAY
World Class Technology Corporation
905.1030-LRGTRAY
In Commercial Distribution

  • 00840273915812 ()
905.1030-LRGTRAY

  • Orthodontic bracket, metal

MAXSO - 00990010301924

MH01,Head, Push Button, CA Burs
Beyes Dental Canada Inc
SL3060
In Commercial Distribution

  • 00990010301924 ()
MH01

  • Dental power tool handpiece motorless component

MAXSO - 00990010301832

CH04,Head, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2010
In Commercial Distribution

  • 00990010301832 ()
CH04

  • Dental power tool handpiece motorless component

MAXSO - 00990010301825

CH02,Head, Push Botton, CA Burs
Beyes Dental Canada Inc
SL2008
In Commercial Distribution

  • 00990010301825 ()
CH02

  • Dental power tool handpiece motorless component

VITROS - 10758750000555

VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800035
In Commercial Distribution

  • 10758750000555 ()
  • 20758750000552 ()
6800035

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750000531

VITROS Immunodiagnostic Products CA 15-3 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800033
In Commercial Distribution

  • 10758750000531 ()
  • 20758750000538 ()
6800033

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251 - 00817302023091

CA (Calcium) 4 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT251
In Commercial Distribution

  • 00817302023091 ()

  • Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert
  • Total Volume: 70 Milliliter
DT251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.™ CA CALCIUM REAGENT CC251 - 00817302020434

CA (Calcium) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC251
In Commercial Distribution

  • 00817302020434 ()

  • Total Volume: 101 Milliliter
  • Kit contains 1 R1 bottle and 1 package insert
CC251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT AU-251 - 00817302020427

CA (Calcium) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-251
In Commercial Distribution

  • 00817302020427 ()

  • Kit contains 1 R1 bottle and 1 package insert
  • Total Volume: 60 Milliliter
AU-251

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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