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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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ASCENT 4 IN 1 RESECTION - 00880304333611

No Description
Biomet Orthopedics, LLC
32-379422
In Commercial Distribution

  • 00880304333611 ()
32-379422

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ASCENT 4 IN 1 RESECTION - 00880304333604

No Description
Biomet Orthopedics, LLC
32-379421
In Commercial Distribution

  • 00880304333604 ()
32-379421

  • Orthopaedic prosthesis implantation positioning instrument, reusable

3/32 IN. GUIDE PIN - 00880304411906

No Description
Biomet Orthopedics, LLC
909640
In Commercial Distribution

  • 00880304411906 ()
909640

  • Surgical drill guide, single-use

Fluoro-CheckTM AMI 3 in 1 - 00895160002496

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
NANO-DITECH CORPORATION
TF3154
In Commercial Distribution

  • 00895160002496 ()
  • 10895160002493 ()
TF3154

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay

Nano-CheckTM 4 in 1 Test - 00895160002458

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma
NANO-DITECH CORPORATION
CD402P
In Commercial Distribution

  • 00895160002458 ()
  • 10895160002455 ()
CD402P

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinical
  • Multiple cardiac marker IVD, reagent

Nano-CheckTM AMI 3 in 1 - 00895160002137

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
NANO-DITECH CORPORATION
CD302P
In Commercial Distribution

  • 00895160002137 ()
  • 10895160002134 ()
CD302P

  • Multiple cardiac marker IVD, reagent

Nano-CheckTM AMI 2 in 1 - 00895160002120

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma
NANO-DITECH CORPORATION
CD202P
Not in Commercial Distribution

  • 00895160002120 ()
  • 10895160002127 ()
CD202P

  • Multiple cardiac marker IVD, reagent

Nano-CheckTM AMI 3 in 1 - 00895160002090

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human serum and plasma
NANO-DITECH CORPORATION
CD301S
In Commercial Distribution

  • 00895160002090 ()
  • 10895160002097 ()
CD301S

  • Multiple cardiac marker IVD, reagent

Nano-CheckTM AMI 2 in 1 - 00895160002083

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human serum and plasma
NANO-DITECH CORPORATION
CD201S
In Commercial Distribution

  • 00895160002083 ()
  • 10895160002080 ()
CD201S

  • Multiple cardiac marker IVD, reagent

I-125 AnchorSeeds in Vile Sterile - 00815165020080

No Description
Eckert & Ziegler Bebig, Inc.
I-125 AnchorSeeds in Vile Sterile
In Commercial Distribution

  • 00815165020080 ()
ASVIALI125

  • Manual brachytherapy system
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