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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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ARCADIUS® XP L - 04046964043642

ARCADIUS XP L IMPLANT 9° 25X35X10MM
Aesculap AG
SO840P
In Commercial Distribution

  • 04046964043642 ()

  • Height : 10.000 MM
  • Degree (°) : 9.000 DEG
  • Length : 25.000 MM
SO840P

  • Metal-polymer composite spinal interbody fusion cage

NovoHip Total Hip System - 00811382038198

Taper Stem, Ext Offset Sz 9
Novosource, LLC
1125-0009
In Commercial Distribution

  • 00811382038198 ()

  • Length: 98 Millimeter
1125-0009

  • Press-fit hip femur prosthesis, one-piece

NovoHip Total Hip System - 00811382038082

Taper Stem, Std Offset Sz 9
Novosource, LLC
1100-0009
In Commercial Distribution

  • 00811382038082 ()

  • Length: 98 Millimeter
1100-0009

  • Press-fit hip femur prosthesis, one-piece

Nucleus - 09321502014731

FREEDOM PROGRAMMING CABLE (2.95M / 9' 8")
COCHLEAR LIMITED
Z60765
In Commercial Distribution

  • 09321502014731 ()

  • 2.95m long cable
  • Length: 2.95 Meter
Z60765

  • Cochlear implant/auditory brainstem implant peripheral connector

VANTAGE™ Anterior Fixation System - 00763000887872

PLATE 9330095 9 5CM ATL TI
MEDTRONIC SOFAMOR DANEK, INC.
9330095
In Commercial Distribution

  • 00763000887872 ()


  • Metallic spinal interbody fusion cage

Fisherbrand - 00613647002858

BNDG FB SLFADH 2 PUR 36/CSBND
FISHER SCIENTIFIC COMPANY L.L.C.
HZ402 NO.9
In Commercial Distribution

  • 20613647002852 ()
  • 00613647002858 ()
  • 10613647002855 ()
22270318

  • Non-adhesive device retention bandage

KerraFoam Gentle Border - 05060077231382

No Description
CRAWFORD HEALTHCARE LIMITED
9 x 10in
In Commercial Distribution

  • 05060077231399 ()
  • 05060077231375 ()
  • 05060077231382 ()

  • Length: 10 Inch
  • Height: 9 Inch
CWL1040

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

NA - 00724995001551

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 9
Not in Commercial Distribution

  • 00724995001551 ()
EPSC009INT

  • Luminal device flushing tubing set, reusable

Orfit Industries - 05420028778449

Screw M6X25 (1 pc.)
Orfit Industries NV
32015/9/5
In Commercial Distribution

  • 05420028778449 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028760079

Grip Pole Short - (set of 2 pieces)
Orfit Industries NV
32015/9/3
In Commercial Distribution

  • 05420028760079 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028760062

Grip Pole Long -(set of 2 pcs)
Orfit Industries NV
32015/9/2
In Commercial Distribution

  • 05420028760062 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028757130

Grip Pole Collar
Orfit Industries NV
32015/9/1
In Commercial Distribution

  • 05420028757130 ()


  • Radiological whole-body positioner

Encore - 00850358007264

No Description
ENCORE, INC.
SILICONE RING #9
In Commercial Distribution

  • 00850358007264 ()
44003-9-001

  • Penile vacuum device

HairMax - 00856823006534

Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
Lexington International, LLC
Ultima 9 Classic
In Commercial Distribution

  • 00856823006534 ()
856823006534

  • Hair growth laser device

Epredia - 00673693089029

The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.
RICHARD-ALLAN SCIENTIFIC COMPANY
Paraffin, Type 9
In Commercial Distribution

  • 00673693089029 ()
8337

  • Paraffin-based embedding medium IVD

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

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 - 04250317364180

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

  • 04250317365057 ()
  • 04250317364180 ()
011799091

  • Microscope slide coverslip IVD

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

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

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
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