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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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40mm Straight Stent (24mm collar)
Artivion, Inc.
K039420
In Commercial Distribution

  • 00877234001192 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length:207mm
  • Stent Collar Diameter: 24mm
AMDS40

  • Bare-metal aortic stent
BioGlue Surgical Adhesive Applicator Tips
Artivion, Inc.
BGAT-SY
In Commercial Distribution

  • 10877234001182 ()
  • 00877234001185 ()
  • 20877234001189 ()

  • Length: 74.25 Millimeter
BGAT-SY

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Delivery Tip Extension
Artivion, Inc.
BGDTE-10
In Commercial Distribution

  • 10877234000932 ()
  • 00877234000935 ()
  • 20877234000939 ()

  • Length: 10 Centimeter
BGDTE-10

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Syringe Spreader Tips
Artivion, Inc.
BGST-12
In Commercial Distribution

  • 10877234000918 ()
  • 00877234000911 ()
  • 20877234000915 ()

  • 12mm tip width
BGST-12

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Syringe Extender Tips
Artivion, Inc.
BGAT-10-SY
In Commercial Distribution

  • 10877234000901 ()
  • 00877234000904 ()
  • 20877234000908 ()

  • Length: 10 Centimeter
BGAT-10-SY

  • Open-surgery adhesive/sealant applicator, dual-channel
No Description
Roche Molecular Systems, Inc.
09040552190
In Commercial Distribution

  • 00875197006896 ()
09040552190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
09040544190
In Commercial Distribution

  • 00875197006889 ()
09040544190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
07460155190
In Commercial Distribution

  • 00875197005752 ()
07460155190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
7258321190
In Commercial Distribution

  • 00875197005592 ()
07258321190

  • Enhancer of zeste homolog 2 (EZH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Imagio Breast Imaging System Model 9100
Seno Medical Instruments, Inc.
9100
In Commercial Distribution

  • 00864802000459 ()
9100-000-02

  • Optoacoustic/ultrasound imaging system
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