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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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A. Titan Instruments - 00841685104252

Plugger, double ended, plugger/explorer
A. TITAN INSTRUMENTS, INC.
RCP 9/11
In Commercial Distribution

  • 00841685104252 ()


  • Endodontic plugger

A. Titan Instruments - 00841685104054

Periodontal File, Schluger, double ended
A. TITAN INSTRUMENTS, INC.
Schluger 9/10
In Commercial Distribution

  • 00841685104054 ()


  • Margin finishing dental file/rasp, reusable

Spectra - 08809108016447

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 28809108016441 ()
  • 08809108016447 ()
MM011343

  • Breast pump, electric

Spectra - 08809108011350

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 28809108011354 ()
  • 18809108011357 ()
  • 08809108011350 ()
  • 18809108013030 ()
  • 28809108013037 ()


  • Breast pump, electric

Spectra - 08809108011343

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 18809108011340 ()
  • 08809108011343 ()
  • 28809108011347 ()


  • Breast pump, electric

Marienfeld Superior - 04250317364180

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1,5H
In Commercial Distribution

  • 04250317365057 ()
  • 04250317364180 ()
011799091

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317356444

No Description
Paul Marienfeld GmbH & Co. KG
9 N.3
In Commercial Distribution

  • 04250317364951 ()
  • 04250317356444 ()
0114990090

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317328168

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1
In Commercial Distribution

  • 04250317365491 ()
  • 04250317328168 ()
011199039169

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317320445

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1,5
In Commercial Distribution

  • 04250317365118 ()
  • 04250317320445 ()
0112990492

  • Microscope slide coverslip IVD

Marienfeld Superior - 04064279011668

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1
In Commercial Distribution

  • 04064279011644 ()
  • 04064279011668 ()
0895003

  • Microscope slide coverslip IVD

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

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

ABSORBENT PAPER POINTS - 08806383514057

"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-.04 9
In Commercial Distribution

  • 08806383514057 ()
205-609

  • Endodontic paper point

ASSORTED BRANDS - 00193033448052

No Description
FGX INTERNATIONAL INC.
DL5582/9.FTG
In Commercial Distribution

  • 00193033448052 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033511572

No Description
FGX INTERNATIONAL INC.
DL5660/9.CGR
In Commercial Distribution

  • 00193033511572 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033543900

No Description
FGX INTERNATIONAL INC.
DL5812/9.FTG
In Commercial Distribution

  • 00193033543900 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033543894

No Description
FGX INTERNATIONAL INC.
DL5816/9.FTG
In Commercial Distribution

  • 00193033543894 ()


  • Tinted non-prescription spectacles

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

Passeo-35 - 07640130434523

No Description
Biotronik AG
9/80/130
Not in Commercial Distribution

  • 07640130434523 ()

  • Usable Length: 130 cm
  • Diameter: 9 mm
  • Length: 80 mm
383270

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434486

No Description
Biotronik AG
9/60/130
Not in Commercial Distribution

  • 07640130434486 ()

  • Diameter: 9 mm
  • Usable Length: 130 cm
  • Length: 60 mm
383266

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434448

No Description
Biotronik AG
9/40/130
Not in Commercial Distribution

  • 07640130434448 ()

  • Usable Length: 130 cm
  • Length: 40 mm
  • Diameter: 9 mm
383262

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434424

No Description
Biotronik AG
9/20/130
Not in Commercial Distribution

  • 07640130434424 ()

  • Usable Length: 130 cm
  • Diameter: 9 mm
  • Length: 20 mm
383260

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434196

No Description
Biotronik AG
9/80/90
Not in Commercial Distribution

  • 07640130434196 ()

  • Length: 80 mm
  • Diameter: 9 mm
  • Usable Length: 90 cm
383237

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434158

No Description
Biotronik AG
9/60/90
Not in Commercial Distribution

  • 07640130434158 ()

  • Usable Length: 90 cm
  • Diameter: 9 mm
  • Length: 60 mm
383233

  • Peripheral angioplasty balloon catheter, basic

Astron - 07640130412460

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

  • 07640130412460 ()

  • Length: 80 mm
  • Usable Length: 130 cm
  • Diameter: 9 mm
364671

  • Peripheral artery stent, bare-metal

Astron - 07640130412453

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

  • 07640130412453 ()

  • Length: 60 mm
  • Diameter: 9 mm
  • Usable Length: 130 cm
364670

  • Peripheral artery stent, bare-metal

Astron - 07640130412446

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

  • 07640130412446 ()

  • Length: 40 mm
  • Usable Length: 130 cm
  • Diameter: 9 mm
364669

  • Peripheral artery stent, bare-metal

Astron - 07640130412439

No Description
Biotronik AG
9/30/130
In Commercial Distribution

  • 07640130412439 ()

  • Length: 30 mm
  • Diameter: 9 mm
  • Usable Length: 130 cm
364668

  • Peripheral artery stent, bare-metal

Astron - 07640130412316

No Description
Biotronik AG
9/80/72
In Commercial Distribution

  • 07640130412316 ()

  • Diameter: 9 mm
  • Length: 80 mm
  • Usable Length: 72 cm
364656

  • Peripheral artery stent, bare-metal

Astron - 07640130412309

No Description
Biotronik AG
9/60/72
In Commercial Distribution

  • 07640130412309 ()

  • Diameter: 9 mm
  • Length: 60 mm
  • Usable Length: 72 cm
364655

  • Peripheral artery stent, bare-metal

Astron - 07640130412293

No Description
Biotronik AG
9/40/72
In Commercial Distribution

  • 07640130412293 ()

  • Usable Length: 72 cm
  • Length: 40 mm
  • Diameter: 9 mm
364654

  • Peripheral artery stent, bare-metal

Astron - 07640130412286

No Description
Biotronik AG
9/30/72
In Commercial Distribution

  • 07640130412286 ()

  • Length: 30 mm
  • Usable Length: 72 cm
  • Diameter: 9 mm
364653

  • Peripheral artery stent, bare-metal

Passeo-35 - 07640119558219

No Description
Biotronik AG
9/40/80
Not in Commercial Distribution

  • 07640119558219 ()

  • Usable Length: 80 cm
  • Length: 40 mm
  • Diameter: 9 mm
357292

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640119558158

No Description
Biotronik AG
9/20/80
Not in Commercial Distribution

  • 07640119558158 ()

  • Diameter: 9 mm
  • Usable Length: 80 cm
  • Length: 20 mm
357286

  • Peripheral angioplasty balloon catheter, basic

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
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