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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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CS2 Acetabular Cup System - 00840286801188

Acetabular Insert, 28mm ID, 58mm
Shalby Advanced Technologies, Inc.
1005-0-2858
In Commercial Distribution

  • 00840286801188 ()
1005-0-2858

  • Non-constrained polyethylene acetabular liner

CS2 Acetabular Cup System - 00840286801157

Acetabular Insert, 28mm ID, 52mm
Shalby Advanced Technologies, Inc.
1005-0-2852
In Commercial Distribution

  • 00840286801157 ()
1005-0-2852

  • Non-constrained polyethylene acetabular liner

CS2 Acetabular Cup System - 00840286801133

Acetabular Insert, 28mm ID, 48mm
Shalby Advanced Technologies, Inc.
1005-0-2848
In Commercial Distribution

  • 00840286801133 ()
1005-0-2848

  • Non-constrained polyethylene acetabular liner

CS2 Acetabular Cup System - 00840286801126

Acetabular Insert, 28mm ID, 46mm
Shalby Advanced Technologies, Inc.
1005-0-2846
In Commercial Distribution

  • 00840286801126 ()
1005-0-2846

  • Non-constrained polyethylene acetabular liner

CS2 Acetabular Cup System - 00840286801119

Acetabular Insert, 22mm ID, 44mm
Shalby Advanced Technologies, Inc.
1005-0-2244
In Commercial Distribution

  • 00840286801119 ()
1005-0-2244

  • Non-constrained polyethylene acetabular liner

CS2 Acetabular Cup System - 00840286801102

Acetabular Insert, 22mm ID, 42mm
Shalby Advanced Technologies, Inc.
1005-0-2242
In Commercial Distribution

  • 00840286801102 ()
1005-0-2242

  • Non-constrained polyethylene acetabular liner

IMMY - 00816387020476

ID Plates, 4 Series, Agarose
Immuno-Mycologics, Inc.
ID1029
In Commercial Distribution

  • 00816387020476 ()


  • Agar medium preparation kit IVD

IMMY - 00816387020254

ID Plates, Single Series, Cleargel
Immuno-Mycologics, Inc.
CA1019
In Commercial Distribution

  • 00816387020254 ()


  • Agar medium preparation kit IVD

IMMY - 00816387020117

Aspergillus terreus ID Positive Control
Immuno-Mycologics, Inc.
AG0110
In Commercial Distribution

  • 00816387020117 ()


  • Multiple Aspergillus species total antibody IVD, control

IMMY - 00816387020094

Aspergillus niger ID Positive Control
Immuno-Mycologics, Inc.
AE0110
In Commercial Distribution

  • 00816387020094 ()


  • Multiple Aspergillus species total antibody IVD, control
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