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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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Invictus - 00190376405971

Favored Angle Screw, CC, 3.5mm X 10mm
ALPHATEC SPINE, INC.
18610-35-10
In Commercial Distribution

  • 00190376405971 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 10 Millimeter


  • Spinal bone screw, non-bioabsorbable

Invictus - 00190376405964

Favored Angle Screw, CC, 3.5mm X 8mm
ALPHATEC SPINE, INC.
18610-35-08
In Commercial Distribution

  • 00190376405964 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 8 Millimeter


  • Spinal bone screw, non-bioabsorbable

Darby Dental Supply, LLC - 00889813009826

REAMERS CC 25MM NO 15-40 AST PK6
DARBY DENTAL SUPPLY, LLC
9512851
In Commercial Distribution

  • 00889813009826 ()
  • 00889813009819 ()
9512851

  • Endodontic reamer

Darby Dental Supply, LLC - 00889813007983

FILES HED CC 31MM NO 30 PK6
DARBY DENTAL SUPPLY, LLC
9512549
In Commercial Distribution

  • 00889813007983 ()
  • 00889813007976 ()
9512549

  • Manual endodontic file/rasp, reusable

Darby Dental Supply, LLC - 00889813007372

REAMERS CC 25MM # 90-110 ASST PK/6
DARBY DENTAL SUPPLY, LLC
9512855
In Commercial Distribution

  • 00889813007372 ()
  • 00889813007365 ()
9512855

  • Endodontic reamer

Darby Dental Supply, LLC - 00889813007358

REAMERS CC 25MM NO 45-80 AST PK6
DARBY DENTAL SUPPLY, LLC
9512853
In Commercial Distribution

  • 00889813007358 ()
  • 00889813007341 ()
9512853

  • Endodontic reamer

Darby Dental Supply, LLC - 00889813007297

FILE K-TYP CC 31MM NO 100 PK6
DARBY DENTAL SUPPLY, LLC
9512755
In Commercial Distribution

  • 00889813007297 ()
  • 00889813007280 ()
9512755

  • Manual endodontic file/rasp, reusable

Darby Dental Supply, LLC - 00889813007273

FILE K-TYP CC 31MM NO 90 PK6
DARBY DENTAL SUPPLY, LLC
9512753
In Commercial Distribution

  • 00889813007273 ()
  • 00889813007266 ()
9512753

  • Manual endodontic file/rasp, reusable

Darby Dental Supply, LLC - 00889813007259

FILES HED CC 25MM NO 50 PK6
DARBY DENTAL SUPPLY, LLC
9512465
In Commercial Distribution

  • 00889813007259 ()
  • 00889813007242 ()
9512465

  • Manual endodontic file/rasp, reusable

Truliant - 10885862526342

TRULIANT CC TIB REAMER BUSHING SIZE 14MM
Exactech, Inc.
02-019-70-1014
In Commercial Distribution

  • 10885862526342 ()

  • Lumen/Inner Diameter: 14 Millimeter
02-019-70-1014

  • Surgical drill guide, reusable

Truliant - 10885862526335

TRULIANT CC TIB REAMER BUSHING SIZE 12MM
Exactech, Inc.
02-019-70-1012
In Commercial Distribution

  • 10885862526335 ()

  • Lumen/Inner Diameter: 12 Millimeter
02-019-70-1012

  • Surgical drill guide, reusable

Truliant - 10885862526328

TRULIANT CC TIB REAMER BUSHING SIZE 10MM
Exactech, Inc.
02-019-70-1010
In Commercial Distribution

  • 10885862526328 ()

  • Lumen/Inner Diameter: 10 Millimeter
02-019-70-1010

  • Surgical drill guide, reusable

Truliant - 10885862522047

TRULIANT CC TIB AUG CUT BLOCK RIGHT
Exactech, Inc.
02-019-70-1007
In Commercial Distribution

  • 10885862522047 ()
02-019-70-1007

  • Osteotomy guide, reusable

Truliant - 10885862522030

TRULIANT CC TIB AUG CUT BLOCK LEFT
Exactech, Inc.
02-019-70-1006
In Commercial Distribution

  • 10885862522030 ()
02-019-70-1006

  • Osteotomy guide, reusable

Truliant - 10885862522009

TRULIANT CC FEMORAL FINISHING GUIDE SIZE 5
Exactech, Inc.
02-019-50-1150
In Commercial Distribution

  • 10885862522009 ()

  • SIZE 5
02-019-50-1150

  • Osteotomy guide, reusable

Truliant - 10885862521996

TRULIANT CC FEMORAL FINISHING GUIDE SIZE 4
Exactech, Inc.
02-019-50-1140
In Commercial Distribution

  • 10885862521996 ()

  • SIZE 4
02-019-50-1140

  • Osteotomy guide, reusable

Truliant - 10885862521989

TRULIANT CC FEMORAL FINISHING GUIDE SIZE 3
Exactech, Inc.
02-019-50-1130
In Commercial Distribution

  • 10885862521989 ()

  • SIZE 3
02-019-50-1130

  • Osteotomy guide, reusable

Truliant - 10885862521972

TRULIANT CC FEMORAL FINISHING GUIDE SIZE 2
Exactech, Inc.
02-019-50-1120
In Commercial Distribution

  • 10885862521972 ()

  • SIZE 2
02-019-50-1120

  • Osteotomy guide, reusable

Truliant - 10885862521965

TRULIANT CC FEMORAL FINISHING GUIDE SIZE 1
Exactech, Inc.
02-019-50-1110
In Commercial Distribution

  • 10885862521965 ()

  • SIZE 1
02-019-50-1110

  • Osteotomy guide, reusable

Millennium - 00190776198169

Toomey cc SS Hub to LL Needlemale
Avalign Technologies, Inc.
39-T60LLSSN
In Commercial Distribution

  • 00190776198169 ()


  • Liposuction system cannula, reusable

Millennium - 00190776195595

Mercedes Cannula Two Piece cc Toomey Hub
Avalign Technologies, Inc.
39-CA3MER0335TMY
In Commercial Distribution

  • 00190776195595 ()


  • Liposuction system cannula, reusable

Millennium - 00190776195519

Mercedes Cannula Two Piece cc Toomey Hub
Avalign Technologies, Inc.
39-CA3MER0325TMY
In Commercial Distribution

  • 00190776195519 ()


  • Body aspiration needle, reusable

Millennium - 00190776195366

Micro Injection Needle Style g LL CC
Avalign Technologies, Inc.
39-MIN11615LLCC
In Commercial Distribution

  • 00190776195366 ()


  • Body aspiration needle, reusable

Millennium - 00190776197148

Tumescent Infiltrator Port cc SS Toomey Hub
Avalign Technologies, Inc.
39-BN90325TMY
In Commercial Distribution

  • 00190776197148 ()


  • Liposuction system cannula, reusable

Millennium - 00190776197131

Tumescent Infiltrator Port cc SS Toomey Hub
Avalign Technologies, Inc.
39-BN90315TMY
In Commercial Distribution

  • 00190776197131 ()


  • Liposuction system cannula, reusable

Millennium - 00190776196561

Mercedes Tip Cannula for cc Toomey Syringe
Avalign Technologies, Inc.
39-CA3MER0415TMY
In Commercial Distribution

  • 00190776196561 ()


  • Liposuction system cannula, reusable

Millennium - 00190776302184

SCISSORS SUTURE WIRE 4" STR SERR (CC)
Avalign Technologies, Inc.
1-049
In Commercial Distribution

  • 00190776302184 ()


  • General-purpose surgical scissors, reusable

Tornado™ - 10840642168709

Bioactive Bone Matrix, 5 cc Moldable Strip
Spine Wave, Inc.
11-5805
In Commercial Distribution

  • 10840642168709 ()

  • 5 cc


  • Bone matrix implant, animal-derived, bioabsorbable

Cortera Spinal Fixation System - 00840311252589

Case, Half, 1 LVL, CC Cann 8.5
Xtant Medical Holdings, Inc.
1509-210080
In Commercial Distribution

  • 00840311252589 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252572

Case, Half, 1 LVL, CC Cann 4.5
Xtant Medical Holdings, Inc.
1509-210070
In Commercial Distribution

  • 00840311252572 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252343

Tray, Full, CC CANN, IMP, Level 3
Xtant Medical Holdings, Inc.
1509-020260
In Commercial Distribution

  • 00840311252343 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252336

Tray, Full, CC CANN, IMP, Level 2
Xtant Medical Holdings, Inc.
1509-020250
In Commercial Distribution

  • 00840311252336 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311252329

Tray, Full, CC CANN, INS, Level 1
Xtant Medical Holdings, Inc.
1509-020240
In Commercial Distribution

  • 00840311252329 ()


  • Instrument tray, reusable

Creation Willi Geller - ECWG0008041

CC/ Kit 1 804 (incl. shade guide)
KLEMA Dentalprodukte GmbH
000804
In Commercial Distribution

  • ECWG0008041 ()
000804

  • Dental appliance fabrication material, ceramic

GEN2 - 00840343726102

CC SPINAL CURETTE STR 13'' 2-0 GOLD
SURGIX MEDICAL LLC
G2N87452
In Commercial Distribution

  • 00840343726102 ()

  • Length: 13 Inch
  • Tip Size 2-0
G2N87452

  • Bone curette, reusable

GEN2 - 00840343714505

CC SPINAL CURETTE REV ANG 10" 5-0
SURGIX MEDICAL LLC
G2N87437
In Commercial Distribution

  • 00840343714505 ()

  • Length: 10 Inch
  • Tip Width 5MM
  • Direction - Rev Ang
G2N87437

  • Bone curette, reusable

NA - 10885862056849

CC KNEE X-RAY TEMPLATE PKG SZ 1
Exactech, Inc.
209-95-00-01
In Commercial Distribution

  • 10885862056849 ()

  • SIZE 1
209-95-00-01

  • Surgical implant template, reusable

NA - 10885862056832

CC KNEE X-RAY TEMPLATE PKG SZ 1-6
Exactech, Inc.
209-95-00
In Commercial Distribution

  • 10885862056832 ()

  • SIZE 1-6
209-95-00

  • Surgical implant template, reusable

NA - 10885862056719

TRIAL, CC STEM EXTENSION, RETAINING SCREW, SHORT
Exactech, Inc.
209-58-01
In Commercial Distribution

  • 10885862056719 ()
209-58-01

  • Knee tibia prosthesis trial, reusable

Medtronic Reusable Instruments - 00199150000685

INSERTER X21520220 15DEG CC 20DE AP LONG
MEDTRONIC SOFAMOR DANEK, INC.
X21520220
In Commercial Distribution

  • 00199150000685 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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