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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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No Description
SKELETAL DYNAMICS L.L.C.
Drill, Solid Side Cutting, 2.0mm x 40mm
In Commercial Distribution

  • 00841506101255 ()

  • Outer Diameter: 2 Millimeter
DRLL-SSC-20040

  • Fluted surgical drill bit, single-use
No Description
SKELETAL DYNAMICS L.L.C.
Drill, Cannulated, Polyaxial Locking Screw, 2.0mm
In Commercial Distribution

  • 00841506101248 ()

  • Outer Diameter: 2 Millimeter
DRLL-PLS-20

  • Cannulated surgical drill bit, single-use
Symmetry® Dilator; Cooley Coronary; 2.0 mm Tip
SYMMETRY SURGICAL INC.
55-7120
In Commercial Distribution

  • 00887482085547 ()

  • Shaft Length: 2 Millimeter
55-7120

  • Vascular dilator, reusable
No Description
Bion Enterprises, Ltd.
HS2-4012
In Commercial Distribution

  • B110HS240120 ()
HS2-4012

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent
PRECICHEK AutoCode Blood Glucose ACH foil packed test strip
HMD BIOMEDICAL INC.
3L-10-16003B
In Commercial Distribution

  • 04260236851210 ()
  • 04260236851142 ()
3L-10-16003B

  • Glucose IVD, kit, electrometry
  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control
HER-2/neu - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308994
In Commercial Distribution

  • 00630414471235 ()
915031

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
Her-2/neu (H2n) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995591
In Commercial Distribution

  • 00630414599151 ()
10995591

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
Not in Commercial Distribution

  • 08305901009155 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
BIOMERICA, INC.
1009-15
In Commercial Distribution

  • 00083059100952 ()


  • Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
Box: 2 varnish, 2 paste, 2 DPA's
YOUNG DENTAL MANUFACTURING I, LLC
295548
In Commercial Distribution

  • 10302732955489 ()


  • Dental coating, tooth-desensitizing
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