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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Screw, Poly, CC Solid, 6.5x35
Xtant Medical Holdings, Inc.
150101-65035
In Commercial Distribution

  • 00840311221042 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 6.5x25
Xtant Medical Holdings, Inc.
150101-65025
In Commercial Distribution

  • 00840311221028 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 6.0x55
Xtant Medical Holdings, Inc.
150101-60055
In Commercial Distribution

  • 00840311221004 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 6.0x45
Xtant Medical Holdings, Inc.
150101-60045
In Commercial Distribution

  • 00840311220984 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 6.0x35
Xtant Medical Holdings, Inc.
150101-60035
In Commercial Distribution

  • 00840311220960 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 6.0x25
Xtant Medical Holdings, Inc.
150101-60025
In Commercial Distribution

  • 00840311220946 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.5x55
Xtant Medical Holdings, Inc.
150101-55055
In Commercial Distribution

  • 00840311220922 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.5x45
Xtant Medical Holdings, Inc.
150101-55045
In Commercial Distribution

  • 00840311220908 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.5x35
Xtant Medical Holdings, Inc.
150101-55035
In Commercial Distribution

  • 00840311220885 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.5x25
Xtant Medical Holdings, Inc.
150101-55025
In Commercial Distribution

  • 00840311220861 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.0x55
Xtant Medical Holdings, Inc.
150101-50055
In Commercial Distribution

  • 00840311220847 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.0x45
Xtant Medical Holdings, Inc.
150101-50045
In Commercial Distribution

  • 00840311220823 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.0x35
Xtant Medical Holdings, Inc.
150101-50035
In Commercial Distribution

  • 00840311220809 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 5.0x25
Xtant Medical Holdings, Inc.
150101-50025
In Commercial Distribution

  • 00840311220786 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 4.5x45
Xtant Medical Holdings, Inc.
150101-45045
In Commercial Distribution

  • 00840311220748 ()


  • Spinal bone screw, non-bioabsorbable
Screw, Poly, CC Solid, 4.5x35
Xtant Medical Holdings, Inc.
150101-45035
In Commercial Distribution

  • 00840311220724 ()


  • Spinal bone screw, non-bioabsorbable
IC Graft Chamber - 15 cc
LIFENET HEALTH
GDS015T
In Commercial Distribution

  • 00889858395519 ()

  • LARGE/15 cc
GDS015T

  • Bone graft syringe, single-use
IC Graft Chamber - 10 cc
LIFENET HEALTH
GDS010T
In Commercial Distribution

  • 00889858395472 ()

  • MEDIUM/10 cc
GDS010T

  • Bone graft syringe, single-use
IC Graft Chamber - 5 cc
LIFENET HEALTH
GDS005T
In Commercial Distribution

  • 00889858395434 ()

  • SMALL/5 cc
GDS005T

  • Bone graft syringe, single-use
FILES HED CC 25MM #8
DARBY DENTAL SUPPLY, LLC
9512440
In Commercial Distribution

  • 00889813040911 ()
  • 00889813040928 ()
9512440

  • Manual endodontic file/rasp, single-use
FILES HED CC 21MM #8
DARBY DENTAL SUPPLY, LLC
9512417
In Commercial Distribution

  • 00889813040898 ()
  • 00889813040904 ()
9512417

  • Manual endodontic file/rasp, single-use
Optium DBM Gel, 3 cc
LIFENET HEALTH
TGEL03
In Commercial Distribution

  • 00889858625708 ()

  • 3 cc
TGEL03

  • Bone matrix implant, human-derived
CC/ Neck Transpa HT-53 sand
KLEMA Dentalprodukte GmbH
005053
In Commercial Distribution

  • 09010782024188 ()
005053

  • Dental appliance fabrication material, ceramic
CC/ Neck Transpa HT-52 khaki
KLEMA Dentalprodukte GmbH
005052
In Commercial Distribution

  • 09010782024171 ()
005052

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-43 (ivory)
KLEMA Dentalprodukte GmbH
005043
In Commercial Distribution

  • 09010782024140 ()
005043

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-41 (D3)
KLEMA Dentalprodukte GmbH
005041
In Commercial Distribution

  • 09010782024133 ()
005041

  • Dental appliance fabrication material, ceramic
CC Gingiva G3 Light pink
KLEMA Dentalprodukte GmbH
001593
In Commercial Distribution

  • 09010782022986 ()
001593

  • Dental appliance fabrication material, ceramic
CC/ Gingiva G2 dark pink
KLEMA Dentalprodukte GmbH
001592
In Commercial Distribution

  • 09010782022979 ()
001592

  • Dental appliance fabrication material, ceramic
CC/ Approx. Dentine AD-2 orange
KLEMA Dentalprodukte GmbH
001569
In Commercial Distribution

  • 09010782022795 ()
001569

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-66 olive
KLEMA Dentalprodukte GmbH
001566
In Commercial Distribution

  • 09010782022771 ()
001566

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-65 gold
KLEMA Dentalprodukte GmbH
001565
In Commercial Distribution

  • 09010782022764 ()
001565

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-64 flamingo
KLEMA Dentalprodukte GmbH
001564
In Commercial Distribution

  • 09010782022757 ()
001564

  • Dental appliance fabrication material, ceramic
CC/ Make In MI-61 ivory
KLEMA Dentalprodukte GmbH
001561
In Commercial Distribution

  • 09010782022726 ()
001561

  • Dental appliance fabrication material, ceramic
CC/ Neck Transpa HT-55 bordeaux
KLEMA Dentalprodukte GmbH
001555
In Commercial Distribution

  • 09010782022702 ()
001555

  • Dental appliance fabrication material, ceramic
CC/ Neck Transpa HT-54 honey
KLEMA Dentalprodukte GmbH
001554
In Commercial Distribution

  • 09010782022696 ()
001554

  • Dental appliance fabrication material, ceramic
CC/ Neck Transpa HT-53 sand
KLEMA Dentalprodukte GmbH
001553
In Commercial Distribution

  • 09010782022689 ()
001553

  • Dental appliance fabrication material, ceramic
CC/ Neck Transpa HT-51 iridescent
KLEMA Dentalprodukte GmbH
001551
In Commercial Distribution

  • 09010782022665 ()
001551

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-44 (cuba)
KLEMA Dentalprodukte GmbH
001544
In Commercial Distribution

  • 09010782022658 ()
001544

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-43 (ivory)
KLEMA Dentalprodukte GmbH
001543
In Commercial Distribution

  • 09010782022641 ()
001543

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-3 orange
KLEMA Dentalprodukte GmbH
000284
In Commercial Distribution

  • 09010782020807 ()
000284

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-2 flamingo
KLEMA Dentalprodukte GmbH
000283
In Commercial Distribution

  • 09010782020791 ()
000283

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-0 white
KLEMA Dentalprodukte GmbH
000281
In Commercial Distribution

  • 09010782020777 ()
000281

  • Dental appliance fabrication material, ceramic
CC/ Dentine D-CW California white
KLEMA Dentalprodukte GmbH
000247
In Commercial Distribution

  • 09010782020500 ()
000247

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-41 (D3)
KLEMA Dentalprodukte GmbH
001541
In Commercial Distribution

  • 09010782022634 ()
001541

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-37 (B4)
KLEMA Dentalprodukte GmbH
001537
In Commercial Distribution

  • 09010782022627 ()
001537

  • Dental appliance fabrication material, ceramic
CC/ Opaque Dentine OD-32 (A2-A3)
KLEMA Dentalprodukte GmbH
001532
In Commercial Distribution

  • 09010782022610 ()
001532

  • Dental appliance fabrication material, ceramic
CC/ Shoulder SP-28 opac yellow
KLEMA Dentalprodukte GmbH
001528
In Commercial Distribution

  • 09010782022580 ()
001528

  • Dental appliance fabrication material, ceramic
CC/ Shoulder SP-26 yellow grey
KLEMA Dentalprodukte GmbH
001526
In Commercial Distribution

  • 09010782022566 ()
001526

  • Dental appliance fabrication material, ceramic
CC/ Shoulder SP-25 red brown
KLEMA Dentalprodukte GmbH
001525
In Commercial Distribution

  • 09010782022559 ()
001525

  • Dental appliance fabrication material, ceramic
CC/ Opaque Modifier OM-16 ocker
KLEMA Dentalprodukte GmbH
001516
In Commercial Distribution

  • 09010782022481 ()
001516

  • Dental appliance fabrication material, ceramic
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