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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CKS Condensed System Case 1
Shalby Advanced Technologies, Inc.
CKSCOND1
In Commercial Distribution

  • 00840286839648 ()
CKSCOND1

  • Surgical instrument/implant rack
28MM BIPOLAR Instrument Case
Shalby Advanced Technologies, Inc.
BIPOLAR28MM
In Commercial Distribution

  • 00840286839631 ()
BIPOLAR28MM

  • Surgical instrument/implant rack
UNISYN Case 6 Half Size Reamers
Shalby Advanced Technologies, Inc.
UNISYNCASE6
In Commercial Distribution

  • 00840286839624 ()
UNISYNCASE6

  • Surgical instrument/implant rack
UNISYN Case 5 Bowed and Distal Pilots
Shalby Advanced Technologies, Inc.
UNISYNCASE5
In Commercial Distribution

  • 00840286839617 ()
UNISYNCASE5

  • Surgical instrument/implant rack
UNISYN Case 4 Larger Reamers and Broaches
Shalby Advanced Technologies, Inc.
UNISYNCASE4
In Commercial Distribution

  • 00840286839600 ()
UNISYNCASE4

  • Surgical instrument/implant rack
UNISYN Case 3 Disassembly and Removal Tools
Shalby Advanced Technologies, Inc.
UNISYNCASE3
In Commercial Distribution

  • 00840286839594 ()
UNISYNCASE3

  • Surgical instrument/implant rack
UNISYN Case 2 Trial Necks and Heads
Shalby Advanced Technologies, Inc.
UNISYNCASE2
In Commercial Distribution

  • 00840286839587 ()
UNISYNCASE2

  • Surgical instrument/implant rack
UNISYN Case 1 Straight Reamers, Distal Pilot
Shalby Advanced Technologies, Inc.
UNISYNCASE1
In Commercial Distribution

  • 00840286839570 ()
UNISYNCASE1

  • Surgical instrument/implant rack
RDP Taperset Instrument Case
Shalby Advanced Technologies, Inc.
TAPERSETCASERDP
In Commercial Distribution

  • 00840286839563 ()
TAPERSETCASERDP

  • Surgical instrument/implant rack
Taperset Case 1
Shalby Advanced Technologies, Inc.
TAPERSETCASE1
In Commercial Distribution

  • 00840286839556 ()
TAPERSETCASE1

  • Surgical instrument/implant rack
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