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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Slim Sigma TLIF CC Blade 70mm
ALPHATEC SPINE, INC.
CI-11840-70
In Commercial Distribution

  • 00840180539538 ()


  • Surgical retraction system, reusable
Slim Sigma TLIF CC Blade 90mm
ALPHATEC SPINE, INC.
CI-11840-90
In Commercial Distribution

  • 00840180539545 ()


  • Surgical retraction system, reusable
CC DRILL GUIDE - THREAD IN, 24MM
ALPHATEC SPINE, INC.
CI-11444-24
In Commercial Distribution

  • 00840180523773 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 22MM
ALPHATEC SPINE, INC.
CI-11444-22
In Commercial Distribution

  • 00840180523766 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 20MM
ALPHATEC SPINE, INC.
CI-11444-20
In Commercial Distribution

  • 00840180523759 ()


  • Surgical drill guide, reusable
CC DRILL GUIDE - THREAD IN, 18MM
ALPHATEC SPINE, INC.
CI-11444-18
In Commercial Distribution

  • 00840180523742 ()


  • Surgical drill guide, reusable
Scanbody Direct Nano Short 3Pod - CC
FAICO MEDICAL LLC
ASBNS00000PPC
Not in Commercial Distribution

  • 00840192718259 ()


  • Dental implant system
REAMERS CC 25MM NO 45 PK6
DARBY DENTAL SUPPLY, LLC
9512827
In Commercial Distribution

  • 00889813009802 ()
  • 00889813009796 ()
9512827

  • Endodontic reamer
REAMERS CC 25MM NO 50 PK6
DARBY DENTAL SUPPLY, LLC
9512829
In Commercial Distribution

  • 00889813007334 ()
  • 00889813007327 ()
9512829

  • Endodontic reamer
REAMERS CC 25MM NO 40 PK6
DARBY DENTAL SUPPLY, LLC
9512825
In Commercial Distribution

  • 00889813007310 ()
  • 00889813007303 ()
9512825

  • Endodontic reamer
Screw, Poly, MIS, CC Cann, 5.5x65
Surgalign Spine Technologies, Inc.
150152-55065
In Commercial Distribution

  • 00840311203727 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x60
Xtant Medical Holdings, Inc.
150152-55060
In Commercial Distribution

  • 00840311203710 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x55
Xtant Medical Holdings, Inc.
150152-55055
In Commercial Distribution

  • 00840311203703 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x50
Xtant Medical Holdings, Inc.
150152-55050
In Commercial Distribution

  • 00840311203697 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x45
Xtant Medical Holdings, Inc.
150152-55045
In Commercial Distribution

  • 00840311203680 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x40
Xtant Medical Holdings, Inc.
150152-55040
In Commercial Distribution

  • 00840311203673 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x35
Xtant Medical Holdings, Inc.
150152-55035
In Commercial Distribution

  • 00840311203666 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.5x25
Xtant Medical Holdings, Inc.
150152-55025
In Commercial Distribution

  • 00840311203642 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x115
Surgalign Spine Technologies, Inc.
150152-50115
In Commercial Distribution

  • 00840311203628 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x105
Surgalign Spine Technologies, Inc.
150152-50105
In Commercial Distribution

  • 00840311203604 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x95
Surgalign Spine Technologies, Inc.
150152-50095
In Commercial Distribution

  • 00840311203581 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x85
Surgalign Spine Technologies, Inc.
150152-50085
In Commercial Distribution

  • 00840311203567 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x75
Surgalign Spine Technologies, Inc.
150152-50075
In Commercial Distribution

  • 00840311203543 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x65
Surgalign Spine Technologies, Inc.
150152-50065
In Commercial Distribution

  • 00840311203529 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 5.0x55
Xtant Medical Holdings, Inc.
150152-50055
In Commercial Distribution

  • 00840311203505 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x120
Surgalign Spine Technologies, Inc.
150152-45120
In Commercial Distribution

  • 00840311203437 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x110
Surgalign Spine Technologies, Inc.
150152-45110
In Commercial Distribution

  • 00840311203413 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x105
Surgalign Spine Technologies, Inc.
150152-45105
In Commercial Distribution

  • 00840311203406 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x100
Surgalign Spine Technologies, Inc.
150152-45100
In Commercial Distribution

  • 00840311203390 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x95
Surgalign Spine Technologies, Inc.
150152-45095
In Commercial Distribution

  • 00840311203383 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x90
Surgalign Spine Technologies, Inc.
150152-45090
In Commercial Distribution

  • 00840311203376 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x85
Surgalign Spine Technologies, Inc.
150152-45085
In Commercial Distribution

  • 00840311203369 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x80
Surgalign Spine Technologies, Inc.
150152-45080
In Commercial Distribution

  • 00840311203352 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x75
Surgalign Spine Technologies, Inc.
150152-45075
In Commercial Distribution

  • 00840311203345 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x70
Surgalign Spine Technologies, Inc.
150152-45070
In Commercial Distribution

  • 00840311203338 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x65
Surgalign Spine Technologies, Inc.
150152-45065
In Commercial Distribution

  • 00840311203321 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x60
Xtant Medical Holdings, Inc.
150152-45060
In Commercial Distribution

  • 00840311203314 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x55
Xtant Medical Holdings, Inc.
150152-45055
In Commercial Distribution

  • 00840311203307 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x50
Xtant Medical Holdings, Inc.
150152-45050
In Commercial Distribution

  • 00840311203291 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x45
Xtant Medical Holdings, Inc.
150152-45045
In Commercial Distribution

  • 00840311203284 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x40
Xtant Medical Holdings, Inc.
150152-45040
In Commercial Distribution

  • 00840311203277 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x35
Xtant Medical Holdings, Inc.
150152-45035
In Commercial Distribution

  • 00840311203260 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x30
Xtant Medical Holdings, Inc.
150152-45030
In Commercial Distribution

  • 00840311203253 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 4.5x25
Xtant Medical Holdings, Inc.
150152-45025
In Commercial Distribution

  • 00840311203246 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x120
Surgalign Spine Technologies, Inc.
150152-95120
In Commercial Distribution

  • 00840311205431 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x100
Surgalign Spine Technologies, Inc.
150152-95100
In Commercial Distribution

  • 00840311205394 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x90
Surgalign Spine Technologies, Inc.
150152-95090
In Commercial Distribution

  • 00840311205370 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x80
Surgalign Spine Technologies, Inc.
150152-95080
In Commercial Distribution

  • 00840311205356 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x30
Xtant Medical Holdings, Inc.
150152-95030
In Commercial Distribution

  • 00840311205257 ()


  • Bone-screw internal spinal fixation system, non-sterile
Screw, Poly, MIS, CC Cann, 9.5x25
Xtant Medical Holdings, Inc.
150152-95025
In Commercial Distribution

  • 00840311205240 ()


  • Bone-screw internal spinal fixation system, non-sterile
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