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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

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

Marienfeld Superior - 04064279011668

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

  • 04064279011644 ()
  • 04064279011668 ()
0895003

  • Microscope slide coverslip IVD

ASSORTED BRANDS - 00193033007280

No Description
FGX INTERNATIONAL INC.
DL4732/9.FTG
In Commercial Distribution

  • 00193033007280 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033014370

No Description
FGX INTERNATIONAL INC.
DL4746/9.AUT
In Commercial Distribution

  • 00193033014370 ()


  • Prescription spectacles

ATHLET - 04047844002407

The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
SIGNUS Medizintechnik GmbH
Main body 9
In Commercial Distribution

  • 04047844002407 ()

  • 42x14x15mm
AT0942

  • Vertebral body prosthesis

ASSORTED BRANDS - 00193033109755

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

  • 00193033109755 ()


  • Tinted non-prescription spectacles

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

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

ASSORTED BRANDS - 00193033511572

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

  • 00193033511572 ()


  • Tinted non-prescription spectacles

Boule Con-Diff Tri-Level - 00812137010230

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control

ASSORTED BRANDS - 00193033448052

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

  • 00193033448052 ()


  • Tinted non-prescription spectacles

MulTipeg™ - 07350096321194

No Description
Integration Diagnostics Sweden AB
MulTipeg™ 9
In Commercial Distribution

  • 07350096321194 ()
55019

  • Multimeter

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 - 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 - 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

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 - 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

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 - 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

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 - 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 - 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

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

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
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