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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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ABSORBENT PAPER POINTS - 08806383514163

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PRO-.06 9
In Commercial Distribution

  • 08806383514163 ()
206-609

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383504065

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PRO-.06 9
In Commercial Distribution

  • 08806383504065 ()
110-609

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383503952

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PRO-.04 9
In Commercial Distribution

  • 08806383503952 ()
109-609

  • Natural gutta-percha

Biotronik Passeo-35 HP - 05391525781594

No Description
CREAGH MEDICAL LIMITED
9/40/75
In Commercial Distribution

  • 05391525781594 ()

  • Usable Length: 75 cm
  • Length: 40 Millimeter
  • Outer Diameter: 9.0 Millimeter
399095

  • Peripheral angioplasty balloon catheter, basic

Ambler Surgical - 00190660092399

#9 knife handle, 4 3/4'', delicate, for blades 10, 11, 12 and 15, flat handle
AMBLER SURGICAL CORP.
#9 knife handle
In Commercial Distribution

  • 00190660092399 ()
38-135

  • Scalpel handle, reusable

RCI Optics - G358142006H780

LIMITED BLACK N BLACK COPPER ATB LTD.
RCI Optics
9 Mile Bank
In Commercial Distribution

  • G358142006H780 ()
141806LTD

  • Tinted non-prescription spectacles

RCI Optics - G358142005H780

LIMITED BLACK N BLACK GREY SRG H780
RCI Optics
9 Mile Bank
In Commercial Distribution

  • G358142005H780 ()
142005H780

  • Tinted non-prescription spectacles

PAINfusor Catheter - 08056459671249

The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
22.5 cm - 9"
In Commercial Distribution

  • 08056459671249 ()
  • 18056459671246 ()

  • Length: 22.5 Centimeter
  • Length: 9 Inch
203.06.10.22US

  • Anaesthesia conduction catheterization kit

HYPE SCV - 03662200025947

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCV 9
In Commercial Distribution

  • 03662200025947 ()


  • Press-fit femoral stem prosthesis

HYPE SCL - 03662200025855

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCL 9
In Commercial Distribution

  • 03662200025855 ()


  • Press-fit femoral stem prosthesis

HYPE SCC - 03662200025756

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCC 9
In Commercial Distribution

  • 03662200025756 ()


  • Press-fit femoral stem prosthesis

HYPE SCS - 03662200025640

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCS 9
In Commercial Distribution

  • 03662200025640 ()


  • Press-fit femoral stem prosthesis

Excyte 20 - 03661540304422

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer
ELITECHGROUP INC.
20 (9 mm)
In Commercial Distribution

  • 03661540304422 ()
EX-10618

  • Erthrocyte sedimentation rate (ESR) analyser IVD

ASSORTED BRANDS - 00193033109755

No Description
FGX INTERNATIONAL INC.
DL4972/9.FWG
In Commercial Distribution

  • 00193033109755 ()


  • Tinted non-prescription spectacles

Orsiro Mission - 07640130455863

No Description
Biotronik AG
4/9/140
In Commercial Distribution

  • 07640130455863 ()

  • Length: 9 mm
  • Usable Length: 140 cm
  • Diameter: 4 mm
453930

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro Mission - 07640130455856

No Description
Biotronik AG
3.5/9/140
In Commercial Distribution

  • 07640130455856 ()

  • Diameter: 3.5 mm
  • Usable Length: 140 cm
  • Length: 9 mm
453929

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro Mission - 07640130455849

No Description
Biotronik AG
3/9/140
In Commercial Distribution

  • 07640130455849 ()

  • Diameter: 3 mm
  • Length: 9 mm
  • Usable Length: 140 cm
453928

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro Mission - 07640130455832

No Description
Biotronik AG
2.75/9/140
In Commercial Distribution

  • 07640130455832 ()

  • Diameter: 2.75 mm
  • Usable Length: 140 cm
  • Length: 9 mm
453927

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro Mission - 07640130455825

No Description
Biotronik AG
2.5/9/140
In Commercial Distribution

  • 07640130455825 ()

  • Usable Length: 140 cm
  • Length: 9 mm
  • Diameter: 2.5 mm
453926

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro Mission - 07640130455818

No Description
Biotronik AG
2.25/9/140
In Commercial Distribution

  • 07640130455818 ()

  • Diameter: 2.25 mm
  • Usable Length: 140 cm
  • Length: 9 mm
453925

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Passeo-35 Xeo - 07640130453470

No Description
Biotronik AG
9/120/170
In Commercial Distribution

  • 07640130453470 ()

  • Length: 120 mm
  • Usable Length: 170 cm
  • Diameter: 9 mm
428976

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130453388

No Description
Biotronik AG
9/100/170
In Commercial Distribution

  • 07640130453388 ()

  • Usable Length: 170 cm
  • Length: 100 mm
  • Diameter: 9 mm
428967

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130453296

No Description
Biotronik AG
9/80/170
In Commercial Distribution

  • 07640130453296 ()

  • Length: 80 mm
  • Diameter: 9 mm
  • Usable Length: 170 cm
428958

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130453203

No Description
Biotronik AG
9/60/170
In Commercial Distribution

  • 07640130453203 ()

  • Diameter: 9 mm
  • Length: 60 mm
  • Usable Length: 170 cm
428949

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130453111

No Description
Biotronik AG
9/40/170
In Commercial Distribution

  • 07640130453111 ()

  • Usable Length: 170 cm
  • Length: 40 mm
  • Diameter: 9 mm
428940

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130453029

No Description
Biotronik AG
9/20/170
In Commercial Distribution

  • 07640130453029 ()

  • Diameter: 9 mm
  • Length: 20 mm
  • Usable Length: 170 cm
428931

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452732

No Description
Biotronik AG
9/120/130
In Commercial Distribution

  • 07640130452732 ()

  • Diameter: 9 mm
  • Length: 120 mm
  • Usable Length: 130 cm
428902

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452640

No Description
Biotronik AG
9/100/130
In Commercial Distribution

  • 07640130452640 ()

  • Length: 100 mm
  • Diameter: 9 mm
  • Usable Length: 130 cm
428893

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452558

No Description
Biotronik AG
9/80/130
In Commercial Distribution

  • 07640130452558 ()

  • Usable Length: 130 cm
  • Length: 80 mm
  • Diameter: 9 mm
428884

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452466

No Description
Biotronik AG
9/60/130
In Commercial Distribution

  • 07640130452466 ()

  • Length: 60 mm
  • Usable Length: 130 cm
  • Diameter: 9 mm
428875

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452374

No Description
Biotronik AG
9/40/130
In Commercial Distribution

  • 07640130452374 ()

  • Diameter: 9 mm
  • Length: 40 mm
  • Usable Length: 130 cm
428866

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130452282

No Description
Biotronik AG
9/20/130
In Commercial Distribution

  • 07640130452282 ()

  • Usable Length: 130 cm
  • Length: 20 mm
  • Diameter: 9 mm
428857

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451995

No Description
Biotronik AG
9/120/90
In Commercial Distribution

  • 07640130451995 ()

  • Usable Length: 90 cm
  • Diameter: 9 mm
  • Length: 120 mm
428828

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451902

No Description
Biotronik AG
9/100/90
In Commercial Distribution

  • 07640130451902 ()

  • Usable Length: 90 cm
  • Length: 100 mm
  • Diameter: 9 mm
428819

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451810

No Description
Biotronik AG
9/80/90
In Commercial Distribution

  • 07640130451810 ()

  • Usable Length: 90 cm
  • Diameter: 9 mm
  • Length: 80 mm
428810

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451728

No Description
Biotronik AG
9/60/90
In Commercial Distribution

  • 07640130451728 ()

  • Length: 60 mm
  • Diameter: 9 mm
  • Usable Length: 90 cm
428801

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451636

No Description
Biotronik AG
9/40/90
In Commercial Distribution

  • 07640130451636 ()

  • Length: 40 mm
  • Diameter: 9 mm
  • Usable Length: 90 cm
428792

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 Xeo - 07640130451544

No Description
Biotronik AG
9/20/90
In Commercial Distribution

  • 07640130451544 ()

  • Length: 20 mm
  • Usable Length: 90 cm
  • Diameter: 9 mm
428783

  • Peripheral angioplasty balloon catheter, basic

Orsiro - 07640130438897

No Description
Biotronik AG
4.0/9/140
Not in Commercial Distribution

  • 07640130438897 ()

  • Diameter: 4 mm
  • Length: 9 mm
  • Usable Length: 140 cm
401734

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro - 07640130438880

No Description
Biotronik AG
3.5/9/140
Not in Commercial Distribution

  • 07640130438880 ()

  • Diameter: 3.5 mm
  • Length: 9 mm
  • Usable Length: 140 cm
401733

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro - 07640130438873

No Description
Biotronik AG
3.0/9/140
Not in Commercial Distribution

  • 07640130438873 ()

  • Usable Length: 140 cm
  • Diameter: 3 mm
  • Length: 9 mm
401732

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro - 07640130438866

No Description
Biotronik AG
2.75/9/140
Not in Commercial Distribution

  • 07640130438866 ()

  • Diameter: 2.75 mm
  • Usable Length: 140 cm
  • Length: 9 mm
401731

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro - 07640130438859

No Description
Biotronik AG
2.5/9/140
Not in Commercial Distribution

  • 07640130438859 ()

  • Usable Length: 140 cm
  • Length: 9 mm
  • Diameter: 2.5 mm
401730

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Orsiro - 07640130438842

No Description
Biotronik AG
2.25/9/140
Not in Commercial Distribution

  • 07640130438842 ()

  • Length: 9 mm
  • Usable Length: 140 cm
  • Diameter: 2.25 mm
401729

  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

PRO-Kinetic Energy - 07640130434868

No Description
Biotronik AG
4.0/9/140
In Commercial Distribution

  • 07640130434868 ()

  • Length: 9 mm
  • Diameter: 4 mm
  • Usable Length: 140 cm
383865

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434851

No Description
Biotronik AG
3.5/9/140
In Commercial Distribution

  • 07640130434851 ()

  • Length: 9 mm
  • Diameter: 3.5 mm
  • Usable Length: 140 cm
383864

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434844

No Description
Biotronik AG
3.0/9/140
In Commercial Distribution

  • 07640130434844 ()

  • Usable Length: 140 cm
  • Diameter: 3 mm
  • Length: 9 mm
383863

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434837

No Description
Biotronik AG
2.75/9/140
In Commercial Distribution

  • 07640130434837 ()

  • Usable Length: 140 cm
  • Diameter: 2.75 mm
  • Length: 9 mm
383862

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434820

No Description
Biotronik AG
2.5/9/140
In Commercial Distribution

  • 07640130434820 ()

  • Usable Length: 140 cm
  • Length: 9 mm
  • Diameter: 2.5 mm
383861

  • Bare-metal coronary artery stent

PRO-Kinetic Energy - 07640130434813

No Description
Biotronik AG
2.25/9/140
In Commercial Distribution

  • 07640130434813 ()

  • Usable Length: 140 cm
  • Diameter: 2.25 mm
  • Length: 9 mm
383860

  • Bare-metal coronary artery stent
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