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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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Optetrak Logic - 10885862281289

LOGIC CC TIB SPINE TRIAL SIZE 1
Exactech, Inc.
02-013-65-1000
In Commercial Distribution

  • 10885862281289 ()

  • SIZE 1
02-013-65-1000

  • Knee tibia prosthesis trial, reusable

Millennium - 00190776198169

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

  • 00190776198169 ()


  • Liposuction system cannula, 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 - 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 - 00190776302184

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

  • 00190776302184 ()


  • General-purpose surgical scissors, 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

IRISpec - 10837461002680

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002680 ()
800-7702

  • Multiple urine analyte IVD, control

IRISpec - 10837461002611

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control

Rayshield - 00840348511079

PHILIPS CC TABLE PAD PRESSURE DISPLACING FOAM
AADCO MEDICAL, INC.
TP-910P
In Commercial Distribution

  • 00840348511079 ()
TP-910P

  • Freestanding patient positioner, reusable

Rayshield - 00840348511062

PHILIPS CC TABLE PAD SUPER SUPPORT FOAM
AADCO MEDICAL, INC.
TP-910C
In Commercial Distribution

  • 00840348511062 ()
TP-910C

  • Freestanding patient positioner, reusable

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

Spacelabs Healthcare - 10841522126079

10 LD PNT CBL PINCH CC/VOYAGER
SPACELABS HEALTHCARE (WASHINGTON), INC
CCOLLECT; CDIRECT; PXCABLES; CD12USB
In Commercial Distribution

  • 10841522126079 ()
25-0021

  • Electrical-only medical device connection cable, reusable

SPACELABS HEALTHCARE - 10841522122705

10 LD PNT CBL PINCH CC/VOYAGER
SPACELABS HEALTHCARE (WASHINGTON), INC
PXCABLES
Not in Commercial Distribution

  • 10841522122705 ()
25-0021

  • Electrical-only medical device connection cable, reusable

AoN Implants - 00840192701701

Z Abutment Engaging - h.3.0 mm. - CC
FAICO MEDICAL LLC
AMO40030ZRNRC
Not in Commercial Distribution

  • 00840192701701 ()


  • Dental implant system

AoN Implants - 00840192701695

Z Abutment Engaging - h.1.5 mm. - CC
FAICO MEDICAL LLC
AMO40015ZRNRC
Not in Commercial Distribution

  • 00840192701695 ()


  • Dental implant system

AoN Implants - 00840192701688

Z Abutment Engaging - h.0.7 mm. - CC
FAICO MEDICAL LLC
AMO40007ZRNRC
Not in Commercial Distribution

  • 00840192701688 ()


  • Dental implant system

AoN Implants - 00840192701541

Slim Clip Transfer - h.9 mm. - CC
FAICO MEDICAL LLC
ATR00SHOIR00C
Not in Commercial Distribution

  • 00840192701541 ()


  • Dental implant system

AoN Implants - 00840192701534

Slim Clip Transfer - h.12 mm. - CC
FAICO MEDICAL LLC
ATR00000IR00C
Not in Commercial Distribution

  • 00840192701534 ()


  • Dental implant system

AoN Implants - 00840192717627

T-Base 3Pod Engaging - h.4.5 mm. - CC
FAICO MEDICAL LLC
ALI0004500NRC
Not in Commercial Distribution

  • 00840192717627 ()


  • Dental implant system

AoN Implants - 00840192717603

T-Base 3Pod Engaging - h.3.0 mm. - CC
FAICO MEDICAL LLC
ALI0003000NRC
Not in Commercial Distribution

  • 00840192717603 ()


  • Dental implant system

AoN Implants - 00840192717580

T-Base 3Pod Engaging - h.1.5 mm. - CC
FAICO MEDICAL LLC
ALI0001500NRC
Not in Commercial Distribution

  • 00840192717580 ()


  • Dental implant system

AoN Implants - 00840192717566

T-Base 3Pod Engaging - h.0.7 mm. - CC
FAICO MEDICAL LLC
ALI0000700NRC
Not in Commercial Distribution

  • 00840192717566 ()


  • Dental implant system

AoN Implants - 00840192717368

T-Base S Engaging - h.4.5 mm. - CC
FAICO MEDICAL LLC
ALS0004500NRC
Not in Commercial Distribution

  • 00840192717368 ()


  • Dental implant system

AoN Implants - 00840192717344

T-Base S Engaging - h.3.0 mm. - CC
FAICO MEDICAL LLC
ALS0003000NRC
Not in Commercial Distribution

  • 00840192717344 ()


  • Dental implant system

AoN Implants - 00840192717320

T-Base S Engaging - h.1.5 mm. - CC
FAICO MEDICAL LLC
ALS0001500NRC
Not in Commercial Distribution

  • 00840192717320 ()


  • Dental implant system

AoN Implants - 00840192717306

T-Base S Engaging - h.0.7 mm. - CC
FAICO MEDICAL LLC
ALS0000700NRC
Not in Commercial Distribution

  • 00840192717306 ()


  • Dental implant system

AoN Implants - 00840192716583

Z Abutment Engaging - h.4.5 mm. - CC
FAICO MEDICAL LLC
AMO40045ZRNRC
Not in Commercial Distribution

  • 00840192716583 ()


  • Dental implant system

AlloFuse® Plus - M536903380101

AlloFuse® Plus DBM Putty, 10 cc
ALLOSOURCE
90338010
In Commercial Distribution

  • M536903380101 ()

  • 10 cc
90338010

  • Bone matrix implant, human-derived

AlloFuse® Plus - M536902380031

AlloFuse® Plus DBM Paste, 3 cc
ALLOSOURCE
90238003
In Commercial Distribution

  • M536902380031 ()

  • 3 cc
90238003

  • Bone matrix implant, human-derived

AlloFuse® Plus - M536902380011

AlloFuse® Plus DBM Paste, 1 cc
ALLOSOURCE
90238001
In Commercial Distribution

  • M536902380011 ()

  • 1 cc
90238001

  • Bone matrix implant, human-derived

Ace Medical Co - 00840217907767

Horseshoe Lock for 20 cc BD Syringe
Ebner Medical, LLC
ECA-A042
In Commercial Distribution

  • 00840217907767 ()


  • Self-retaining surgical retractor, reusable

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

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

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

Medicrea|UNiD MIS - 03613720290230

UNID EXP B33256099-01 CC PERC 6.0 1-3L
MEDICREA INTERNATIONAL
B33256099-01
In Commercial Distribution

  • 03613720290230 ()


  • Bone-screw internal spinal fixation system rod

Medicrea|UNiD ROD - 03613720289791

UNID EXP B33244699-01 DUAL 4.75/6.0 CC
MEDICREA INTERNATIONAL
B33244699-01
In Commercial Distribution

  • 03613720289791 ()


  • Bone-screw internal spinal fixation system rod
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