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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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size 1, small, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-01
In Commercial Distribution

  • 04250381858646 ()
50-245-01

  • Mouthguard, reusable
size 2, medium, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-02
In Commercial Distribution

  • 04250381858639 ()
50-245-02

  • Mouthguard, reusable
size 3, large, with holes
Spiggle & Theis Medizintechnik GmbH
50-245-03
In Commercial Distribution

  • 04250381858622 ()
50-245-03

  • Mouthguard, reusable
Orthex Pin Bolt with washer
VILEX IN TENNESSEE, INC.
C660
In Commercial Distribution

  • 00841731112507 ()
C660

  • External orthopaedic fixation system, single-use
iBlock Sawing Guide with Cutout
Omni Life Science, Inc.
XK-06449
In Commercial Distribution

  • 00841690195320 ()
XK-06449

  • Orthopaedic prosthesis implantation positioning instrument, reusable
GROUNDING LEAD WITH LIP CLIP
Kerr Corporation
973-0226
In Commercial Distribution

  • 00195062030086 ()


  • Dental pulp analysis system
Hex Driver with Handle, 5.0
CTL Medical Corporation
015.7081
In Commercial Distribution

  • 00841732108042 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver with Handle, 3.0
CTL Medical Corporation
016.7052
In Commercial Distribution

  • 00841732108950 ()


  • Surgical screwdriver, reusable
Hex Driver with Handle, 2.35
CTL Medical Corporation
010.7061
In Commercial Distribution

  • 00841732101074 ()
010.7061

  • Spinal fixation plate, non-bioabsorbable
Orthex Strut Diagonal with QC
VILEX IN TENNESSEE, INC.
390-045-Q
In Commercial Distribution

  • 00841731114747 ()


  • External orthopaedic fixation system, single-use
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